PFD report

Margaret Elizabeth Clark · Prevention of Future Deaths report

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Issued 10 Feb 2018•Lancashire and Blackburn with Darwen

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
1

Raised in this report

Recipients
1

Named on the report

Responses found
1

Of 1 recipient

Stated actions
2

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 raised1

  1. Use of Ecolab sheaths creating increased resistance on insertion
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.2

  1. Action

    Continue monitoring the safety of TOE probe covers.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 8 June 2018.
  2. Action

    Review adverse-incident reports relating to Ecolab sheaths and TOE probe covers.

    Stated by Medicines and Healthcare products Regulatory AgencyStated completedThe respondent said that this action was complete when they made their response on 8 June 2018.

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

  1. Position

    Inability to compare sheath softness prevents recommending replacement of Ecolab sheaths across hospitals and trusts.

    Stated by Medicines and Healthcare products Regulatory AgencyUnable to actThe respondent said that a constraint prevented them from taking the relevant 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

Use of Ecolab sheaths creating increased resistance on insertion

Wider context from the report

“I was told that in 2017 the types of probes used for TOEs were changed, to a design which required covering with a sheath. Using that sheath, three fatal oesophageal tears had occurred in the space of 5 months, involving in each case experienced anaesthetists who had conducted TOEs routinely for many years without event. [I was told that there had been one previous incident in the preceding 16 years]. The sheaths used – Ecolab Ultracover for TEE – were replaced at Blackpool Victoria Hospital with alternative [softer] sheaths – Probetecion TOE/TEE Transducer Kit. Since the replacement sheaths have been used, there have been no incidents of tear. I was told that the Ecolab sheaths may still be used in other hospitals and Trusts. A Serious Incident Investigation Report expressed a concern that the tears may have resulted from the use of the Ecolab sheaths, which [it was felt] created more resistance on insertion than had been the case before their use. (1) I believe you should review the use of the Ecolab sheaths and consider whether they should not be replaced in all hospitals and Trusts by the Protec[tion] sheaths. ”

Is this part of a recurring concern?

No recurring-concern membership is currently published.

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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 safety of TOE probe covers.

Verbatim wording from the response

“The safety of TOE probe covers will continue to be monitored and appropriate regulatory action to protect public health will be taken as and when necessary.”

Source location

2018-0050-Response-by-MHRA
Page 1 · response
Published 8 June 2018

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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

Review adverse-incident reports relating to Ecolab sheaths and TOE probe covers.

Verbatim wording from the response

“The MHRA performed a review of the adverse incident database, looking for incidents relating to Ecolab sheaths and found only two reports that relate to TOE probe covers splitting, this includes the report from Blackpool Victoria Hospital.”

Source location

2018-0050-Response-by-MHRA
Page 1 · response
Published 8 June 2018

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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

Inability to compare sheath softness prevents recommending replacement of Ecolab sheaths across hospitals and trusts.

Verbatim wording from the response

“The MHRA are unable to compare “softness” of sheaths on the market and therefore cannot recommend that Ecolab sheaths are replaced in all hospitals and Trusts by the Protection sheaths.”

Source location

2018-0050-Response-by-MHRA
Page 1 · response
Published 8 June 2018

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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