11 Aug 2015 John Hills · Prevention of Future Deaths report West Sussex
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Concerns raised 5 Failure to review and address fire risks of lower-paraffin emollient creams View source Lack of community information about paraffin-emollient ignition risk View source Fire hazard from paraffin-based emollients contacting clothing or dressings View source Failure to consider paraffin-emollient fire risk when prescribing View source Failure to communicate paraffin-emollient fire risk to patients View source See 2 more concerns
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AI-generated summary
John Hills · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
John Hills, a resident of a nursing home, suffered fatal burns after his clothing and blankets caught fire while he was smoking in the conservatory. The report raised concerns about the failure to ensure he was wearing his fire-retardant apron and about insufficient awareness, communication and prevention of the fire risks associated with paraffin-based emollient creams such as Cetraben, particularly in community care settings.
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How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to review and address fire risks of lower-paraffin emollient creams
Wider context from the report “(5) The NPSA carried a Rapid Response Warning (and report) on 26 November 2007 providing background and recommendations on the use of paraffin based products, but focused (as does the BNF) on (non-proprietary emollient preparations, specifically) emulsifying ointments or 50% plus paraffin content emollients. It is not clear whether this has been recently reviewed or whether the potential risk of lower % paraffin content creams has been considered and addressed.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of community information about paraffin-emollient ignition risk
Wider context from the report “(7) Cetraben and Diprobase are proprietary emollient preparations in wide application in non-hospital environments, notably care homes, but also in private nursing and home care. It appears that there is little information conveyed or publicised about the potential risk of ignition/fire outside of hospitals or other clinical treatment areas , particularly where the cream is in frequent application and clothing (or bedding) has a high risk of becoming soaked or soiled by repeated application and contact.
(8) I am concerned about the potential risks associated with Cetraben (and associated lower % creams) and the level of awareness, communication and prevention of such risks in the community. I believe this should be considered, the risks assessed and action taken, as appropriate.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Fire hazard from paraffin-based emollients contacting clothing or dressings
Wider context from the report “(2) Diprobase emollient cream (the next ‘greasy’ preparation product and next step up from Cetraben) contains 21% paraffin content (15% white soft paraffin and 6% liquid paraffin) but 7.2% alcohol, and carries a fire hazard warning on prescription: ‘Dressing and clothing in contact with this product are easily ignited by a naked flame – Keep away’ (the product bottle itself has not been examined for warnings during the course of my enquiries).
(3) The British National Formulary does not list either product specifically as being flammable, but does contain a general warning for paraffin based emollients that reads: “Fire hazard with paraffin-based emollients: Emulsifying ointment or 50% liquid paraffin and 50% white soft paraffin ointment in contact with dressings and clothing is easily ignited by a naked flame. The risk is greater when these preparations are applied to large areas of the body, and clothing or dressings become soaked with the ointment. Patients should be kept away from fire or flames and not to smoke when using these preparations. The risk of fire should be considered when using large quantities of any paraffin-based emollient”
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to consider paraffin-emollient fire risk when prescribing
Wider context from the report “(4) Mr Hills was clearly recorded (in his medical notes) as being a chronic smoker with acute bronchitis. He was also recorded as being a pipe smoker (in his medical records on 13/10/14) yet had a repeat prescription for Cetraben 500 gram being recorded on 11/09/14. There is nothing to evidence that any risk was considered or communicated by either the GP surgery or the prescribing pharmacy.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to communicate paraffin-emollient fire risk to patients
Wider context from the report “(4) Mr Hills was clearly recorded (in his medical notes) as being a chronic smoker with acute bronchitis. He was also recorded as being a pipe smoker (in his medical records on 13/10/14) yet had a repeat prescription for Cetraben 500 gram being recorded on 11/09/14. There is nothing to evidence that any risk was considered or communicated by either the GP surgery or the prescribing pharmacy.
” Open source report
12 Nov 2014 Patricia Ann Mellor · Prevention of Future Deaths report Nottinghamshire
View report summary
Concerns raised 6 Failure to include warnings about cardiac arrest risks in inhalational anaesthetic product information for patients with LQTS View source Failure to update guidance to require specific examination of the QTc interval in all pre-operative ECGs View source Failure to update pre-operative assessment guidance to require consideration of drug-induced LQTS before omitting a 12 lead ECG View source Failure to include warnings about cardiac arrest risks in product information for other drugs used during inhalational anaesthesia in patients with LQTS View source Failure to update guidance to require 12 lead ECG recording and QTc examination for patients receiving drugs at high or intermediate risk of inducing cardiac arrest in LQTS View source Failure to highlight issues involving antidepressant agents and LQTS in regular agency bulletins View source See 3 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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AI-generated summary
Patricia Ann Mellor · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
Patricia Ann Mellor suffered a cardiac arrest during general anaesthesia in 2004, resulting in a hypoxic brain injury and severe disability. She died from aspiration pneumonia on 24 January 2014. The investigation identified acquired Long QT Syndrome associated with a combination of citalopram, nortriptyline and ranitidine, and concerns were raised about the need to identify and manage this risk before anaesthesia.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to include warnings about cardiac arrest risks in inhalational anaesthetic product information for patients with LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to update guidance to require specific examination of the QTc interval in all pre-operative ECGs
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to update pre-operative assessment guidance to require consideration of drug-induced LQTS before omitting a 12 lead ECG
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to include warnings about cardiac arrest risks in product information for other drugs used during inhalational anaesthesia in patients with LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to update guidance to require 12 lead ECG recording and QTc examination for patients receiving drugs at high or intermediate risk of inducing cardiac arrest in LQTS
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to highlight issues involving antidepressant agents and LQTS in regular agency bulletins
Wider context from the report “There were further communications with the MHRA suggesting that;
· The product information for inhalational anaesthetic agents should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS
· The product information for other drugs such as 5HT₃ anti-emetics should contain a warning on the potential risks of cardiac arrest when administered to patients with LQTS during inhalational anaesthesia
· The particular issues with antidepressant agents and LQTS should be highlighted in the regular bulletins from the Agency
Furthermore, ████████ reported that recommendations be sent to NICE updating guideline CG3 to;
· Instruct anaesthetists to consider drug-induced LQTS in their pre-operative assessment before following the recommendation not to perform a 12 lead ECG
· Instruct anaesthetists to specifically examine the QTc interval in all pre-operative ECGs performed for any indication
· To require a 12 lead ECG to be recorded and the QTc to be specifically examined in all patients receiving aged deemed to be of “high” and “intermediate” risk of inducing cardiac arrest in LQTS
· ████████ advised that despite the above notifications and recommendations, no action has been taken by these agencies .
” Open source report
Concerns raised 1 Lack of inclusion of the risk of severe seizures in prescribing warnings for venlafaxine and similar antidepressants View source
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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AI-generated summary
George Stone · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
George Stone suffered from long-term depressive illness and ended his own life on 19 November 2012 after a grand mal seizure following treatment with Venlafaxine. The concern was that severe seizures are a rare side effect of Venlafaxine and similar antidepressants, but the national warning guidelines did not then include the risk of severe seizures.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Lack of inclusion of the risk of severe seizures in prescribing warnings for venlafaxine and similar antidepressants
Wider context from the report “I was told in evidence at the Inquest that a side effect of Venlafaxine and similar antidepressants is seizures and that although this is rare, these seizures can be very severe - as was the case with George Stone. I was also told that the NPSA issues national guidelines for the warnings practitioners must give their patients who are prescribed these sorts of antidepressants but the risk of patients suffering a severe seizure is not included in the guidelines at the present time .
” Open source report
1 Jul 2014 John Henry ADAMS · Prevention of Future Deaths report Brighton and Hove
View report summary
Concerns raised 8 Use of trial operators with limited on-site availability and experience View source Insufficient time for trial information review and informed consent before procedures View source Inaccurate terminology about the cause of procedural injury View source Failure to communicate trial involvement and suspected trial-related events to receiving clinicians View source Failure to ensure adequate information for trial clinicians View source Failure to notify the Coroner of a trial patient's death and trial involvement View source Conduct of trial procedures under competing time pressure View source Failure to record suspected trial-related causes in hospital notes View source See 5 more concerns
Responses linked to these concerns
Each statement is shown once, even when linked to more than one concern.
No linked response statements No action or position from this recipient is clearly linked to the concerns in this report.
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AI-generated summary
John Henry ADAMS · Prevention of Future Deaths report
This summary was generated using AI from the published report. Please read the original report for the complete account.
Report summary
John Henry Adams died following multiple complications of an appropriate cardiac intervention after being recruited to a cardiac trial just before the procedure. Concerns included whether there was sufficient time for informed consent, the suitability and preparedness of the trial operator, and the recording and communication of the trial’s possible relevance to the cardiac tamponade and subsequent death.
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× Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Use of trial operators with limited on-site availability and experience
Wider context from the report “(4) Is it appropriate for a visiting Cardiologist, only present at the Hospital for a few hours every fortnight to be the "operator" to take part in this trial ?
(5) Given that the Consultant Cardiologist in Mr. Adams' case does only visit Brighton once a fortnight for a few hours, and this was his first patient on the Trial, was he himself appropriately informed?
In evidence I was told that he was already late for a Clinic when he left the Hospital, believing that Mr. Adams was fine, and that involvement in the trial meant that the procedure took longer than normal - possibly about half an hour longer.
Does that sort of pressure result in the best outcome?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Insufficient time for trial information review and informed consent before procedures
Wider context from the report “(2) Was it appropriate that he should have been recruited within an hour or so prior to his procedure commencing ?
(3) Did this give him time to read the several page booklet which was provided to him and to absorb the information and give informed consent?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Inaccurate terminology about the cause of procedural injury
Wider context from the report “(7) The hospital notes in Brighton, the letter of referral to Kings College Hospital and the report to the Coroner all gave the impression, because of the wording used, that what had happened at the PCI was that the diagonal artery had dissected and this is what is believed to have caused the pericardial effusion and tamponade.
The Consultant Cardiologist is the only person to have used the expression "dissection" to describe the damage to the diagonal artery which occurred during the PCI.
Should more care be taken in terminology? In this case it seems to have lead to a great deal of confusion.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to communicate trial involvement and suspected trial-related events to receiving clinicians
Wider context from the report “(8) One of the organisers of the Trial has written in Mr. Adams' notes that he has been notified of what has happened to Mr. Adams but he makes no mention of what is believed to have occurred as a result of the Trial . Why not?
Why was the Trial not mentioned to Kings College Hospital in the Referral letter dated the 1st February 2014?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to ensure adequate information for trial clinicians
Wider context from the report “(4) Is it appropriate for a visiting Cardiologist, only present at the Hospital for a few hours every fortnight to be the "operator" to take part in this trial?
(5) Given that the Consultant Cardiologist in Mr. Adams' case does only visit Brighton once a fortnight for a few hours, and this was his first patient on the Trial, was he himself appropriately informed?
In evidence I was told that he was already late for a Clinic when he left the Hospital, believing that Mr. Adams was fine, and that involvement in the trial meant that the procedure took longer than normal - possibly about half an hour longer.
Does that sort of pressure result in the best outcome?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to notify the Coroner of a trial patient's death and trial involvement
Wider context from the report “(9) Finally; surely the death of a patient while on a Trial is a matter of major concern to the Trial itself and yet no-one contacted the Coroner , either the original Coroner in South London or me, Coroner for Brighton and Hove when I took over jurisdiction pursuant to Section 2 of the Coroner’s and Justice Act, to let us know that this man had been on a Trial .
If I had known that, and in particular if I had been able to tell ████████ of that fact, she would have been able to ascertain precisely where the bleeding/haemorrhage originated and there would have been good clear helpful information for those managing the Trial and of course future patients who might have benefited from it.
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Conduct of trial procedures under competing time pressure
Wider context from the report “(4) Is it appropriate for a visiting Cardiologist, only present at the Hospital for a few hours every fortnight to be the "operator" to take part in this trial?
(5) Given that the Consultant Cardiologist in Mr. Adams' case does only visit Brighton once a fortnight for a few hours, and this was his first patient on the Trial, was he himself appropriately informed?
In evidence I was told that he was already late for a Clinic when he left the Hospital , believing that Mr. Adams was fine, and that involvement in the trial meant that the procedure took longer than normal - possibly about half an hour longer .
Does that sort of pressure result in the best outcome?
” Open source report × Source evidence
How this individual concern was interpreted PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to National Patient Safety Agency; that does not assign responsibility.
PFD Monitor interpretation Failure to record suspected trial-related causes in hospital notes
Wider context from the report “(6) The Hospital notes for Mr. Adams admission on the 30th do not mention the view (apparently formed within an hour or so of surgery), that it was the pacing wires; which was the extra requirement of the Trial; which caused the cardiac tamponade .
Why not? Why was this information effectively concealed?
” Open source report