PFD report

Susan Warby · Prevention of Future Deaths report

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Issued 25 Sep 2020•Suffolk

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.

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Concerns
2

Raised in this report

Recipients
2

Named on the report

Responses found
2

Of 2 recipients

Stated actions
3

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

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Report evidence summary

Concerns raised2

  1. Insufficiently distinctive packaging and visual identification of intravenous fluids for arterial line transducer sets
    Part of recurring concern: Failure to ensure medication packaging is clearly distinguishablePart of recurring concern: Failure to ensure safety-critical medical equipment is reliably visually identifiable
  2. Failure to use the correct technique when drawing blood samples from arterial lines
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

    Consider improvements with the marketing authorisation holder to make statutory information easier for clinical staff to assimilate and reduce selection errors.

    Stated by Medicines and Healthcare products Regulatory AgencyStated plannedThe respondent said that this action was planned when they made their response on 23 November 2020.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.4

  1. Position

    Relevant professional bodies are responsible for education and training matters concerning arterial-line competencies.

    Stated by Department of Health and Social CareRedirects responsibilityThe respondent said that another organisation was responsible for deciding or taking action.

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

Insufficiently distinctive packaging and visual identification of intravenous fluids for arterial line transducer sets

Wider context from the report

“1. During the evidence it was clear that packaging and visual identification aids available for intravenous fluids to be used in arterial line transducer sets were not sufficiently distinctive. It was heard that following Mrs Warby's death that as far as possible the West Suffolk Hospital has asked its suppliers to change the labelling on the intravenous fluids it purchases. These were exhibited in court and even with the changes the manufacture was prepared to make, the packaging cannot be considered at all distinctive for fluids to be used in an arterial line. In direct contrast, we saw that the tubing used on an arterial line transducer set has a solid red line running its length. This is to clearly indicate to staff that it is an arterial line therefore must not be used for the administration of drugs or medicinal fluids. I am therefore concerned that the packaging of the 0.9% Sodium Chloride intravenous fluid to be used with an arterial line is not also so clearly distinguished. It was heard in evidence that there is currently no 0.9% Sodium Chloride intravenous fluid available which is specifically and clearly labelled for arterial line use only. It is important to note that the issue identified in this inquest regarding the use of incorrect intravenous fluid in an arterial line is not a new one. In 2008 the UK National Patient Safety Agency issued a Rapid Response report highlighting problems with infusions and sampling from arterial lines. In that 2008 report the UK National Patient Safety Agency had already identified 84 incidents where the wrong infusion was attached to an arterial line with two of those cases proving fatal. It is understood that the 0.9% Sodium Chloride intravenous fluid has a number of medicinal uses other than just as a flushing fluid in an arterial line. However, the number of cases identified where the incorrect fluid is being used in arterial lines, clearly demonstrates the confusion and errors which occur when using generally labelled intravenous fluids with an arterial line transusion set. ”

Is this part of a recurring concern?

Yes — Failure to ensure medication packaging is clearly distinguishable; Failure to ensure safety-critical medical equipment is reliably visually identifiable.

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 use the correct technique when drawing blood samples from arterial lines

Wider context from the report

“2. The court was told that the medical staff taking blood samples from the arterial line transducer sets were not using the correct technique to ensure erroneous blood samples were not taken. The court heard that even if the incorrect intravenous fluid is fitted to an arterial line, a good technique used by staff (ensuring to fully account for the ‘dead space’ when drawing the blood sample) would prevent false readings being obtained. As such, in Mrs Warby's case the error of the incorrect intravenous fluid being fitted to her arterial line was exacerbated by medical staff using an incorrect technique when drawing her blood samples. The court was told that training in drawing blood from an arterial line is given as part of standard training for staff caring for patients with an arterial line in place. However, there were a number of erroneous samples taken in Mrs Warby's case, these samples being taken by a number of different staff. As such, the West Suffolk Hospital has already implemented new training and operational regimes for its staff. However, given the apparent prevalence of errors regarding the incorrect use of intravenous fluids and incorrect blood sampling techniques involving arterial lines, a review of training and operational regimes may be considered necessary on a wider basis. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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

Consider improvements with the marketing authorisation holder to make statutory information easier for clinical staff to assimilate and reduce selection errors.

Verbatim wording from the response

“Nonetheless, we will consider further with the marketing authorisation holder whether improvements could be made to assist clinical staff to more easily assimilate the statutory information to reduce the likelihood of errors of this nature in future.”

Source location

2020-0188-Response-from-MHRA-Redacted.pdf
Page 1 · response
Published 23 November 2020

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

Relevant professional bodies are responsible for education and training matters concerning arterial-line competencies.

Verbatim wording from the response

“I hope this clarification is helpful. Education and training are also matters for the relevant professional bodies and my officials have brought the matters of concern in your report to the attention of the Nursing and Midwifery Council and the General Medical Council for their information and consideration.”

Source location

2020-0188-Response-from-Dept.-of-Health-and-Social-Care-Redacted.pdf
Page 2 · response
Published 23 November 2020

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

Employers are responsible for providing post-registration arterial-line training and blood-sampling training to relevant staff.

Verbatim wording from the response

“For nurses, this is a post-registration competency for which the employer has a responsibility to provide training. It is not an expected competency for undergraduate nursing. I am further advised that medical students would not be expected to have this competency and it is not contained in the curriculum for medical undergraduate training. The insertion of arterial cannula is contained in a small number of postgraduate medical curricula and the competencies are assessed and monitored through standard educational procedures.”

Source location

2020-0188-Response-from-Dept.-of-Health-and-Social-Care-Redacted.pdf
Page 2 · response
Published 23 November 2020

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

Colour cannot be used in IV-fluid labelling because container manufacturing prevents it; other local risk controls are required.

Verbatim wording from the response

“You will also know that the MHRA has explained that the way in which the containers of the IV fluids described in your report are manufactured (bags composed of polyolefin/polyamide co-extruded plastic), means that judicious use of colour cannot be used within the labelling to aid differentiation and reduce the likelihood of error at the point of selection. The MHRA states that other risk minimisation measures should be employed locally within clinical areas to assist correct identification. However, the MHRA has undertaken to consider further with the marketing authorisation holder whether improvements can be made to the labelling to help ensure the medicine is used appropriately and reduce the likelihood of such errors in future.”

Source location

2020-0188-Response-from-Dept.-of-Health-and-Social-Care-Redacted.pdf
Page 2 · response
Published 23 November 2020

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

Because Viaflo containers cannot use colour differentiation, local clinical areas must implement other measures to identify intravenous fluids correctly.

Verbatim wording from the response

“Intravenous fluids as described in your report are supplied in bags known as ‘Viaflo’ which are composed of polyolefin/polyamide co-extruded plastic. The way that these containers are manufactured means that ‘judicious use of colour’ (as recommended in our best practice guidance) cannot be used within the labelling, to aid differentiation and reduce the likelihood of error at the point of selection. As a result, other risk minimisation measures must be employed locally within clinical areas to assist in the correct identification of intravenous fluids one from another.”

Source location

2020-0188-Response-from-MHRA-Redacted.pdf
Page 1 · response
Published 23 November 2020

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.2

  1. 1

    Instruct NHS England and NHS Improvement to commission a rapid independent review of the related whistleblowing incident.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 23 November 2020.
  2. 2

    Bring the report’s concerns to the attention of relevant professional, regulatory and patient-safety bodies.

    Stated by Department of Health and Social CareStated completedThe respondent said that this action was complete when they made their response on 23 November 2020.

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

Instruct NHS England and NHS Improvement to commission a rapid independent review of the related whistleblowing incident.

Verbatim wording from the response

“Finally, you may be aware that in January 2020, the Government instructed NHSEI to commission a rapid independent review into a whistleblowing incident related to Mrs Warby’s death. The terms of reference for the review are published online². NHSEI has advised that the review is now expected to be completed by the Spring of this year.”

Source location

2020-0188-Response-from-Dept.-of-Health-and-Social-Care-Redacted.pdf
Page 3 · response
Published 23 November 2020

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

Bring the report’s concerns to the attention of relevant professional, regulatory and patient-safety bodies.

Verbatim wording from the response

“I hope this clarification is helpful. Education and training are also matters for the relevant professional bodies and my officials have brought the matters of concern in your report to the attention of the Nursing and Midwifery Council and the General Medical Council for their information and consideration.”

Source location

2020-0188-Response-from-Dept.-of-Health-and-Social-Care-Redacted.pdf
Page 2 · response
Published 23 November 2020

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