PFD report

Mr Matthews · Prevention of Future Deaths report

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Issued 26 May 2016•County Durham and Darlington

Report record

Published report and response evidence

This page connects the concerns raised in this report with statements found in recipients’ published responses. A link shows a clear evidence connection; it does not assign responsibility.

View original report
Concerns
6

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
6

Described in responses

Source document

Full report text

This is the full text from the original published report.

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Concerns and recipient responses

Select any concern, action or position to view the source wording.

Report evidence summary

Concerns raised6

  1. Failure to prescribe and record oxygen flow rates on the drug chart
    Part of recurring concern: Unsafe provision of oxygen therapy
  2. Failure to investigate oxygen concentrator incidents
    Part of recurring concern: Inadequate safety incident investigations
  3. Failure to ensure administration of oxygen at the prescribed rate
    Part of recurring concern: Unreliable oxygen administration and clinical oversightPart of recurring concern: Unsafe provision of oxygen therapy
Responses linked to these concerns

Each statement is shown once, even when linked to more than one concern.

Actions described in response An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.1

  1. Action

    Continue monitoring the situation and investigate further adverse incidents involving the flowmeter.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 26 July 2016.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.1

  1. Position

    The Oxylitre instructions for use provide sufficient pre-use inspection guidance, making additional specific leak-test instructions unnecessary.

    Stated by Medicines and Healthcare products Regulatory AgencyExisting arrangements considered sufficientThe respondent said that existing arrangements were sufficient, so no further action was needed.

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to prescribe and record oxygen flow rates on the drug chart

Wider context from the report

“(2) Notwithstanding the conclusion of the manufactuer that the oxygen was still being delivered by the device in the right concentration, I am concerned that there was no system in place to ensure that the oxygen was being administered at the prescribed rate. An oxygen concentrator had been set up for use by the patient and the flow rate had been set at 2 litres per minute. The Trust's policy states that all oxygen must be prescribed and the prescribed rate should be recorded on the drug chart. The oxygen was not prescribed on the drug chart and the flow rate was not recorded. This meant that staff were unaware of the prescribed rate and there was no means of checking that the concentrator was delivering the prescribed flow rate. (3) The Trust's policy for oxygen states that oxygen must be prescribed and that the prescribed rate should be recorded on the drug chart. However, no such prescription was made in the drug chart and no record was made of the flow rate. ”

Is this part of a recurring concern?

Yes — Unsafe provision of oxygen therapy.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to investigate oxygen concentrator incidents

Wider context from the report

“(4) The Clinical Engineering Team Leader and the manufacturer concur that the damage to the oxygen concentrator was caused by an accident and that the damage was not responsible for the death. Nevertheless, I am concerned that the incident was not reported to the manufacturer at the time and that no investigation was carried out. The Trust has subsequently reviewed its incident reporting policy and the manufacturer has reviewed its own policy. ”

Is this part of a recurring concern?

Yes — Inadequate safety incident investigations.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to ensure administration of oxygen at the prescribed rate

Wider context from the report

“(2) Notwithstanding the conclusion of the manufactuer that the oxygen was still being delivered by the device in the right concentration, I am concerned that there was no system in place to ensure that the oxygen was being administered at the prescribed rate. An oxygen concentrator had been set up for use by the patient and the flow rate had been set at 2 litres per minute. The Trust's policy states that all oxygen must be prescribed and the prescribed rate should be recorded on the drug chart. The oxygen was not prescribed on the drug chart and the flow rate was not recorded. This meant that staff were unaware of the prescribed rate and there was no means of checking that the concentrator was delivering the prescribed flow rate. (3) The Trust's policy for oxygen states that oxygen must be prescribed and that the prescribed rate should be recorded on the drug chart. However, no such prescription was made in the drug chart and no record was made of the flow rate. ”

Is this part of a recurring concern?

Yes — Unreliable oxygen administration and clinical oversight; Unsafe provision of oxygen therapy.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to report oxygen concentrator incidents to the manufacturer

Wider context from the report

“(4) The Clinical Engineering Team Leader and the manufacturer concur that the damage to the oxygen concentrator was caused by an accident and that the damage was not responsible for the death. Nevertheless, I am concerned that the incident was not reported to the manufacturer at the time and that no investigation was carried out. The Trust has subsequently reviewed its incident reporting policy and the manufacturer has reviewed its own policy. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to specify action when an oxygen concentrator is not working correctly

Wider context from the report

“(5) There was no system in place to ensure that the oxygen concentrator was working correctly. It does not state precisely how to check the amount of oxygen delivered by the device, nor does it state what action should be taken if the device is not working correctly. ”

Is this part of a recurring concern?

Yes — Unreliable oxygen concentrator safety controls.

Open source report

Source evidence

How this individual concern was interpreted

PFD Monitor created a concise, searchable interpretation from the report wording shown below. Response links show a clear evidence connection; they do not assign responsibility.

PFD Monitor interpretation

Failure to specify checks of oxygen concentrator output

Wider context from the report

“(5) There was no system in place to ensure that the oxygen concentrator was working correctly. It does not state precisely how to check the amount of oxygen delivered by the device, nor does it state what action should be taken if the device is not working correctly. ”

Is this part of a recurring concern?

Yes — Unreliable oxygen concentrator safety controls.

Open source report

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Continue monitoring the situation and investigate further adverse incidents involving the flowmeter.

Verbatim wording from the response

“The MHRA is continuing to monitor this situation and will investigate any further incidents that we receive.”

Source location

2016-0276-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Page 3 · response
Published 26 July 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

The Oxylitre instructions for use provide sufficient pre-use inspection guidance, making additional specific leak-test instructions unnecessary.

Verbatim wording from the response

“The IFU states “No leaks are permissible on the device”, and advises the user to visually check the device for cracks before use. A user who identifies a crack should discard the product prior to patient use.”

Source location

2016-0276-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 26 July 2016

Open published response

Other statements in published responses

These actions and other statements could not be clearly connected to one concern in this report.

Recipient-stated actions An action is something a recipient says it has done, is doing, or plans to do in response to a concern raised.5

  1. 1

    Forward concerns to Oxylitre and request evaluation of additional clarity for the next instructions-for-use revision.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 26 July 2016.
  2. 2

    Assess manufacturers’ instructions for use to compare the adequacy of pre-use checks for the Oxylitre flowmeter.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 26 July 2016.
  3. 3

    Introduce full weekly flowmeter checks by equipment controllers and department managers, using a checklist and reporting damage to Clinical Engineering.

    Stated by County Durham and Darlington NHS Foundation TrustStated plannedThe respondent said that this action was planned when they made their response on 26 July 2016.
  4. 4

    Raise flowmeter safety concerns through nursing leadership and governance meetings, and reinforce staff checks for damage and audible gas leaks.

    Stated by County Durham and Darlington NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 26 July 2016.
  5. 5

    Check all Trust oxygen flowmeters and log and report identified faults to department managers.

    Stated by County Durham and Darlington NHS Foundation TrustStated completedThe respondent said that this action was complete when they made their response on 26 July 2016.

Recipient positions A position is what a recipient says about a concern when they do not describe a specific action.2

  1. 1

    MHRA identified no systemic problem involving cracked Oxylitre flowmeters, and the device remained functional despite exceeding its recommended service life.

    Stated by Medicines and Healthcare products Regulatory AgencyDisputes the concernThe respondent disagreed with part of the concern or the basis for it.
  2. 2

    Healthcare organisations are responsible for ensuring their medical devices are appropriately maintained, including maintenance and repair arrangements.

    Stated by Medicines and Healthcare products Regulatory AgencyRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Forward concerns to Oxylitre and request evaluation of additional clarity for the next instructions-for-use revision.

Verbatim wording from the response

“We have undertaken a comparative assessment of various manufacturers’ IFUs for similar devices to determine whether there are any insufficiencies in the pre-use checks description for the Oxylitre flowmeter. The information collected indicates that the Oxylitre IFU provides sufficient guidance for the user to perform pre-use checks and is in line with alternative products. Although the IFU appears sufficient, we have forwarded your concerns regarding clarity and completeness of guidance to Oxylitre for their consideration in their next revision.”

Source location

2016-0276-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 26 July 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Assess manufacturers’ instructions for use to compare the adequacy of pre-use checks for the Oxylitre flowmeter.

Verbatim wording from the response

“We have undertaken a comparative assessment of various manufacturers’ IFUs for similar devices to determine whether there are any insufficiencies in the pre-use checks description for the Oxylitre flowmeter. The information collected indicates that the Oxylitre IFU provides sufficient guidance for the user to perform pre-use checks and is in line with alternative products. Although the IFU appears sufficient, we have forwarded your concerns regarding clarity and completeness of guidance to Oxylitre for their consideration in their next revision.”

Source location

2016-0276-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 26 July 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Introduce full weekly flowmeter checks by equipment controllers and department managers, using a checklist and reporting damage to Clinical Engineering.

Verbatim wording from the response

“All Equipment Controllers/Department Managers to perform a full weekly check of all their flowmeters and report any damage to their local Clinical Engineering departments. A checklist has been devised by the Medical Devices Nurse and will be discussed at the next meeting of the National Association of Medical and Educational Trainers (NANDET) (next meeting 21/09/16) before being utilised across the organisation.”

Source location

2016-0276-Response-by-County-Durham-and-Darlington-NHS-Trust
Page 4 · response
Published 26 July 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Raise flowmeter safety concerns through nursing leadership and governance meetings, and reinforce staff checks for damage and audible gas leaks.

Verbatim wording from the response

“I have ensured that this issue has been raised at the Senior Nurse Leadership Group and all Care Group Governance Meetings within the organisation. All Associate Directors of Nursing have discussed this with clinical staff in all departments to reinforce the importance of checking oxygen flowmeters which includes any detection of audible hissing indicating a leaking of gas from the device.”

Source location

2016-0276-Response-by-County-Durham-and-Darlington-NHS-Trust
Page 4 · response
Published 26 July 2016

Open published response

Source evidence

How this respondent action was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Check all Trust oxygen flowmeters and log and report identified faults to department managers.

Verbatim wording from the response

“1. All oxygen flowmeters across the Trust have been checked by the Clinical Engineering Department and any faults logged and reported to Department Managers”

Source location

2016-0276-Response-by-County-Durham-and-Darlington-NHS-Trust
Page 4 · response
Published 26 July 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

MHRA identified no systemic problem involving cracked Oxylitre flowmeters, and the device remained functional despite exceeding its recommended service life.

Verbatim wording from the response

“The manufacturer’s investigation identified that the cracked flowmeter was still capable of supplying oxygen at the maximum flowrate.”

Source location

2016-0276-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Page 3 · response
Published 26 July 2016

Open published response

Source evidence

How this respondent position was interpreted

PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

PFD Monitor interpretation

Healthcare organisations are responsible for ensuring their medical devices are appropriately maintained, including maintenance and repair arrangements.

Verbatim wording from the response

“Additional Guidance General guidance can be found in the MHRA’s publication Managing Medical Devices (appendix 5). The purpose of this document is to outline a systematic approach to the acquisition, deployment, maintenance, repair and disposal of all medical devices. It is intended primarily for people in hospital and community based organisations who are responsible for the management of reusable medical devices to help them promote safe and effective use of medical devices. The document, which can be applied to oxygen flowmeters, states that a healthcare organisation’s medical device management policy must cover the provision of maintenance and repair of all”

Source location

2016-0276-Response-by-Medicines-and-Healthcare-Products-Regulatory-Agency
Page 2 · response
Published 26 July 2016

Open published response
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Information checked against the published report and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Official responses located
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Data last updated 7 September 2026