PFD report

Benjamin Daniel Rowley · Prevention of Future Deaths report

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Issued 1 Apr 2026•Greater Lincolnshire

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
3

Named on the report

Responses found
3

Of 3 recipients

Stated actions
20

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 raised1

  1. Failure of the permanent bond between CVC venous ports and silicone rubber tubing
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.13

  1. Action

    Update patient information materials with actions to take if catheter integrity is compromised.

    Stated by University Hospitals of Leicester NHS TrustStated plannedThe respondent said that this action was planned when they made their response on 2 April 2026.
  2. Action

    Complete a formal risk assessment of haemodialysis catheter recurrence risk and controls.

    Stated by University Hospitals of Leicester NHS TrustStated completedThe respondent said that this action was complete when they made their response on 2 April 2026.
  3. Action

    Provide home haemodialysis patients using catheters with guidance on luer-end integrity checks and escalation procedures.

    Stated by University Hospitals of Leicester NHS TrustStated completedThe respondent said that this action was complete when they made their response on 2 April 2026.

Respondent positions A position is what a recipient says about a concern when it does not describe a specific action.3

  1. Position

    The likelihood of recurrence is low, and there is no evidence of widespread haemodialysis catheter device failure locally or nationally.

    Stated by University Hospitals of Leicester NHS TrustDisputes the concernThe respondent disagreed with part of the concern or the basis for it.

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 of the permanent bond between CVC venous ports and silicone rubber tubing

Wider context from the report

““The CVC consists of a number of parts that are assembled during the manufacturing process. The two ports consist of a brown and a blue plastic Luer Lock connector permanently bonded to silicone rubber tubes that enter the ‘Y’ shaped connector. A white plastic sleeve is present at the point the ports enter the rubber tubing. These ports are not intended to ever be removed or detached from the silicone rubber tubes. The integrity of the permanent bond between the ports and the tubing is essential for the safety of the CVC. [Mr Rowley] died due to exsanguination caused by a mechanical failure of the CVC. The direct cause was failure of the bond between the venous port of the CVC and the tubing, allowing the port to detach thereby causing blood returning from the machine to the patient to be expelled.” In relation to the later incident of 11 December 2025, the relevant section of the preliminary report states: “The nature of the failure of this CVC appears to be identical to that of Mr Rowley, namely detachment of one port of the CVC from the silicone rubber tube. The direct cause was failure of the bond between the venous port of the CVC and the tubing, allowing the port to detach thereby causing blood returning from the machine to the patient to be expelled. The nature of the failure appears identical...” The report concludes that: “I am concerned that these events could represent a more widespread vulnerability of this brand or of dialysis lines and recommend reporting these events to the Medicines and Healthcare products Regulatory Agency (MHRA).” I endorse those concerns. ”

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

Update patient information materials with actions to take if catheter integrity is compromised.

Verbatim wording from the response

“As part of the Trust’s ongoing response and learning from this incident, the following actions have been agreed:”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 2 · response
Published 2 April 2026

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

Complete a formal risk assessment of haemodialysis catheter recurrence risk and controls.

Verbatim wording from the response

“A formal risk assessment has since been completed by the UHL renal service. This concluded that:”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 1 · response
Published 2 April 2026

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

Provide home haemodialysis patients using catheters with guidance on luer-end integrity checks and escalation procedures.

Verbatim wording from the response

“Following the incidents, DaVita issued a national safety bulletin across all of its UK dialysis units. Within UHL, the incident and associated learning were shared with all dialysis nursing teams, and staff were instructed to undertake mandatory checking of the luer connection during every dialysis session. The incident and actions taken were also discussed at the Midlands Lead Dialysis Nurses Forum. In addition, education and guidance regarding luer-end integrity checks and escalation procedures were provided to home haemodialysis patients using dialysis catheters.”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 2 · response
Published 2 April 2026

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

Update dialysis access care plans to document luer-end checks and catheter details.

Verbatim wording from the response

“As part of the Trust’s ongoing response and learning from this incident, the following actions have been agreed:”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 2 · response
Published 2 April 2026

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

Require dialysis staff to check the catheter luer connection during every dialysis session.

Verbatim wording from the response

“Following the incidents, DaVita issued a national safety bulletin across all of its UK dialysis units. Within UHL, the incident and associated learning were shared with all dialysis nursing teams, and staff were instructed to undertake mandatory checking of the luer connection during every dialysis session. The incident and actions taken were also discussed at the Midlands Lead Dialysis Nurses Forum. In addition, education and guidance regarding luer-end integrity checks and escalation procedures were provided to home haemodialysis patients using dialysis catheters.”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 2 · response
Published 2 April 2026

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

Review the manufacturer’s investigation and available safety data for evidence of a wider catheter detachment or bonding-failure trend.

Verbatim wording from the response

“Review of the available UK data within the MHRA’s safety database did not identify additional reports that would indicate a wider potential safety concern. This is reflected in the legal manufacturer’s data, particularly when accounting for global use and sales. The MHRA has also reviewed the accompanying Instructions For Use (IFU) and determined that whilst the documents are in line with the legal requirements, improvements can be made to provide users with guidance on catheter line durability, maintenance and repair. The MHRA is working with the manufacturer in addressing this.”

Source location

Response from Medicines and Healthcare Products Regulatory Agency
Page 3 · response
Published 2 April 2026

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

Put measures in place to increase monitoring of events involving Covidien Palindrome Chronic Dual Lumen Catheters through vigilance activities.

Verbatim wording from the response

“• The MHRA has put in place measures to increase monitoring of events related to Covidien Palindrome Chronic Dual Lumen Catheters and will continue to review these as part of our vigilance activities. Any further regulatory actions required following this will be communicated via the usual routes.”

Source location

Response from Medicines and Healthcare Products Regulatory Agency
Page 3 · response
Published 2 April 2026

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

Obtain routine updates from the manufacturer on UK and global reports of venous-port detachment and mechanical bond failure while its investigation continues.

Verbatim wording from the response

“• The MHRA has reviewed the investigation undertaken by Mozarc Medical in response to these two events of venous port detachment. Based on the limited number of UK and global reports, there does not appear to be a batch or device trend indicating a wider issue with a failure in bonding of components of this catheter type observed at this time. No root cause has been identified by the company based on their product and manufacturing analysis. The MHRA has asked Mozarc Medical to provide routine updates on the number of UK and global reports concerning venous port detachment and mechanical bond failure, whilst this investigation is ongoing. This is in addition to their routine post-marketing surveillance requirements.”

Source location

Response from Medicines and Healthcare Products Regulatory Agency
Page 3 · response
Published 2 April 2026

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

Conduct a detailed internal investigation into factors that may have contributed to the incidents and assess available information about catheter condition and performance.

Verbatim wording from the response

“We have initiated a detailed internal investigation, to better understand the factors that may have contributed to the incidents described. This work remains ongoing, and we have not reached any final conclusions at this stage. To support a thorough evaluation, it would be of”

Source location

Response from Mozarc Medical
Page 1 · response
Published 2 April 2026

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

Engage with the reporting clinic to gather information and understand the reported events.

Verbatim wording from the response

“We have engaged with the reporting clinic identified in your report, University Hospitals of Leicester, through appropriate channels, to support information gathering and to better understand the circumstances surrounding the events described. We appreciate the cooperation that has been provided to date.”

Source location

Response from Mozarc Medical
Page 1 · response
Published 2 April 2026

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

Log both incidents in the quality system as part of post-market surveillance.

Verbatim wording from the response

“In line with our established post market surveillance process, we have logged both incidents in our quality system as the initial step in our evaluation process. As part of the process, we have undertaken a review of the available complaint data. We will continue to actively monitor incoming data as part of our ongoing vigilance activities.”

Source location

Response from Mozarc Medical
Page 1 · response
Published 2 April 2026

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

Review available complaint data through the post-market surveillance process.

Verbatim wording from the response

“In line with our established post market surveillance process, we have logged both incidents in our quality system as the initial step in our evaluation process. As part of the process, we have undertaken a review of the available complaint data. We will continue to actively monitor incoming data as part of our ongoing vigilance activities.”

Source location

Response from Mozarc Medical
Page 1 · response
Published 2 April 2026

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

Continue monitoring incoming data through ongoing vigilance activities.

Verbatim wording from the response

“In line with our established post market surveillance process, we have logged both incidents in our quality system as the initial step in our evaluation process. As part of the process, we have undertaken a review of the available complaint data. We will continue to actively monitor incoming data as part of our ongoing vigilance activities.”

Source location

Response from Mozarc Medical
Page 1 · response
Published 2 April 2026

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 likelihood of recurrence is low, and there is no evidence of widespread haemodialysis catheter device failure locally or nationally.

Verbatim wording from the response

“• The likelihood of recurrence is low;”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 1 · response
Published 2 April 2026

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

Continued use of current haemodialysis catheters with enhanced surveillance is considered safer and clinically appropriate than routine elective replacement.

Verbatim wording from the response

“• Routine elective replacement of long-term haemodialysis catheters would introduce greater patient risk, including procedural complications, venous stenosis, and potential loss of vascular access, when compared with continued use supported by enhanced surveillance and monitoring arrangements.”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 1 · response
Published 2 April 2026

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

Available UK and global data do not indicate a batch or device trend showing a wider bonding failure issue at this time.

Verbatim wording from the response

“• The MHRA has reviewed the investigation undertaken by Mozarc Medical in response to these two events of venous port detachment. Based on the limited number of UK and global reports, there does not appear to be a batch or device trend indicating a wider issue with a failure in bonding of components of this catheter type observed at this time. No root cause has been identified by the company based on their product and manufacturing analysis. The MHRA has asked Mozarc Medical to provide routine updates on the number of UK and global reports concerning venous port detachment and mechanical bond failure, whilst this investigation is ongoing. This is in addition to their routine post-marketing surveillance requirements.”

Source location

Response from Medicines and Healthcare Products Regulatory Agency
Page 3 · response
Published 2 April 2026

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.7

  1. 1

    Share the incident and learning with all UHL dialysis nursing teams and discuss it at the regional dialysis nurses forum.

    Stated by University Hospitals of Leicester NHS TrustStated completedThe respondent said that this action was complete when they made their response on 2 April 2026.
  2. 2

    Continue work to reduce the proportion of patients dialysing via CVCs toward the national target of less than 20%.

    Stated by University Hospitals of Leicester NHS TrustStated in progressThe respondent said that this action was in progress when they made their response on 2 April 2026.
  3. 3

    Raise catheter longevity and device-learning issues at national renal forums.

    Stated by University Hospitals of Leicester NHS TrustStated plannedThe respondent said that this action was planned when they made their response on 2 April 2026.
  4. 4

    Develop a central electronic record of dialysis catheter type, insertion date and insertion location across the renal network.

    Stated by University Hospitals of Leicester NHS TrustStated plannedThe respondent said that this action was planned when they made their response on 2 April 2026.
  5. 5

    Implement three-monthly catheter site photography aligned with arteriovenous fistula surveillance processes.

    Stated by University Hospitals of Leicester NHS TrustStated plannedThe respondent said that this action was planned when they made their response on 2 April 2026.
  6. 6

    Review the catheter Instructions for Use and work with the manufacturer to improve guidance on durability, maintenance and repair.

    Stated by Medicines and Healthcare products Regulatory AgencyStated in progressThe respondent said that this action was in progress when they made their response on 2 April 2026.
  7. 7

    Continue working with the MHRA as the review progresses.

    Stated by Mozarc MedicalStated in progressThe respondent said that this action was in progress when they made their response on 2 April 2026.

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

Share the incident and learning with all UHL dialysis nursing teams and discuss it at the regional dialysis nurses forum.

Verbatim wording from the response

“Following the incidents, DaVita issued a national safety bulletin across all of its UK dialysis units. Within UHL, the incident and associated learning were shared with all dialysis nursing teams, and staff were instructed to undertake mandatory checking of the luer connection during every dialysis session. The incident and actions taken were also discussed at the Midlands Lead Dialysis Nurses Forum. In addition, education and guidance regarding luer-end integrity checks and escalation procedures were provided to home haemodialysis patients using dialysis catheters.”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 2 · response
Published 2 April 2026

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

Continue work to reduce the proportion of patients dialysing via CVCs toward the national target of less than 20%.

Verbatim wording from the response

“• Continued work to reduce the proportion of patients dialysing via CVCs across the dialysis network toward the nationally recommended target of less than 20%.”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 3 · response
Published 2 April 2026

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 catheter longevity and device-learning issues at national renal forums.

Verbatim wording from the response

“• Raising issues relating to catheter longevity and device learning at national renal forums by Q3 2026;”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 3 · response
Published 2 April 2026

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

Develop a central electronic record of dialysis catheter type, insertion date and insertion location across the renal network.

Verbatim wording from the response

“As part of the Trust’s ongoing response and learning from this incident, the following actions have been agreed:”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 2 · response
Published 2 April 2026

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

Implement three-monthly catheter site photography aligned with arteriovenous fistula surveillance processes.

Verbatim wording from the response

“• Implementation of three-monthly catheter site photography aligned to arteriovenous fistula surveillance processes;”

Source location

Response from University Hospitals of Leicester NHS Trust
Page 3 · response
Published 2 April 2026

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

Review the catheter Instructions for Use and work with the manufacturer to improve guidance on durability, maintenance and repair.

Verbatim wording from the response

“Review of the available UK data within the MHRA’s safety database did not identify additional reports that would indicate a wider potential safety concern. This is reflected in the legal manufacturer’s data, particularly when accounting for global use and sales. The MHRA has also reviewed the accompanying Instructions For Use (IFU) and determined that whilst the documents are in line with the legal requirements, improvements can be made to provide users with guidance on catheter line durability, maintenance and repair. The MHRA is working with the manufacturer in addressing this.”

Source location

Response from Medicines and Healthcare Products Regulatory Agency
Page 3 · response
Published 2 April 2026

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

Continue working with the MHRA as the review progresses.

Verbatim wording from the response

“Additionally, Mozarc Medical is in active communication with the Medicines and Healthcare products Regulatory Agency (MHRA) regarding these matters, including a recent meeting held on 11 May 2026. We will continue to work constructively with the MHRA as our review progresses.”

Source location

Response from Mozarc Medical
Page 1 · response
Published 2 April 2026

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