Benjamin Rowley

Dear Mr. Smith,

We acknowledge receipt of your Regulation 28 Report to Prevent Future Deaths dated 1 April 2026, and we thank you for bringing these important matters to our attention. Mozarc Medical was informed of this matter by Medtronic Limited and is responding in relation to the product referenced in your report.

We extend our sincere condolences to Mr. Rowley’s family. We recognize the seriousness of the circumstances described in your report and share your commitment to patient safety. We are treating the matters referred to in your report with the utmost seriousness.

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.

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.

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.

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

significant benefit to examine the devices referenced in your report. We fully recognize that these items may form part of the coroner’s investigation; however, should it be possible to facilitate return of the devices for controlled analysis, or alternatively to arrange examination in situ or obtain additional detailed imagery or documentation, we would welcome the opportunity to coordinate such efforts in a manner that supports your process. Could you please let us know if you would be willing to send the devices to us or enable our in situ examination?

Our priority at this stage is to continue gathering and assessing all available information to better understand the condition and performance of the catheters referenced, and to determine whether any further actions may be warranted.

We remain committed to supporting the investigation and to taking any appropriate actions necessary to protect patient safety. We appreciate the matters of concern you have raised and the opportunity to respond. We will wait to hear from you regarding the possibility of us examining the devices and we look forward to continuing engagement as additional information becomes available.

RESPONSE TO A REPORT TO PREVENT FUTURE DEATHS REGULATION 29 OF THE CORONERS (INVESTIGATIONS) REGULATIONS 2013 Please do not include any living persons’ names in this document, in accordance with the Chief Coroner’s PFD Publication Policy (2026). THIS RESPONSE IS BEING SENT TO: The Senior Coroner, Paul D Smith for the Coroner Area of Greater Lincolnshire in response to a ‘REPORT TO PREVENT FUTURE DEATH REGULATION 28’ following an inquest into the death of Mr Benjamin Daniel Rowley that has not yet been heard, where the investigation was initiated on 20 November 2025.

1. RESPONDENT In line with our duty under Regulation 29 of the Coroners (Investigations) Regulations 2013, Medicines and Healthcare products Regulatory Agency provides this response within 56 days (plus any extension granted) of the date of the Report to Prevent Future Deaths.
2. DATE OF RESPONSE 25 May 2026
3. CONFIRMATION OF CORONER’S MATTERS OF CONCERN The MATTERS OF CONCERN were identified in the report are as follows: Following investigation and independent examination of the CVCs used in the two patients, the root cause of the detachment has been attributed to the failure of the bond between the venous port of the CVC and the tubing. Concerns were endorsed by the coroner that these events could represent a more widespread vulnerability of this brand or batch of dialysis lines and it was recommended that these events are reported to the Medicines and Healthcare products Regulatory Agency (MHRA).

3. DETAILS OF ACTION TAKEN, how has the concern been addressed. [If no action is proposed please explain why here]. Thank you for your Regulation 28 report dated 1st May 2026 in which you asked the Medicines and Healthcare products Regulatory Agency (MHRA) to provide a response following the ongoing investigation and inquest into the death of Mr Rowley. We are saddened to hear of the death of Mr Rowley and offer our sincere condolences to his family.

I am writing in relation to the concerns raised in your report where you considered that the MHRA should take action to prevent similar events of this kind occurring in the future.

To provide relevant background, the MHRA is an executive agency of the Department of Health and Social care with responsibility for delivering the regulation of medicines and medical devices with the objective that they meet appropriate standards of quality, efficacy and safety. The Human Medicines Regulations 2012 (HMRs) lays out the conditions of the licencing and marketing of a medicine, and the Medical Devices Regulations 2002 underpins the requirements legal manufacturers of medical devices must meet to legally place a device on the market. This has recently been updated with the Medicines and Medical Devices Act 2021, which provides the legal framework to update regulations on medical devices, aiming to improve patient safety, increase transparency, and align with international standards. We take all reasonable steps to protect public health and safeguard patients, the public and users. The MHRA has reviewed the details outlined in the Regulation 28 report to prevent future deaths and below addresses those which fall within the remit of the MHRA. The matters of concern raised in the report are as follows:
1. Two separate incidents concerning Covidien Palindrome Chronic Dual Lumen Catheters, of different batches, relating to the detachment of the venous port of the central venous catheter (CVC) from the silicone tubing attributed to the mechanical failure of the bond between these components.
2. Concern that this may represent a more widespread vulnerability of this brand or batch of dialysis lines and these events should be reported to the MHRA.

The MHRA can confirm that we are in receipt of both incident reports from the University Hospitals of Leicester NHS Trust discussed within this Regulation 28 report, both from the original healthcare professional reporter, as well as the corresponding vigilance report from the legal manufacturer, Mozarc Medical. It is important to note that Mozarc Medical is an independent company supported by investment between Medtronic, Inc. and DaVita Inc, focussing on kidney- related health technologies.

As part of our regulatory responsibility, the MHRA has followed up with Mozarc Medical after receiving these incident reports. The MHRA requested the number of global and UK reports relating to detachment events in the past 5 years, if a root cause for this detachment has been identified or otherwise investigated, as well as for copies of the associated risk evaluation documents associated with these types of events. At this time, no batch-specific or manufacturing issues have been able to be identified, and a root cause for this mechanical failure has not otherwise been determined or communicated to the MHRA. In the second serious case which resulted in blood loss inappropriate catheter repair was reported; the manufacturer has stated to the MHRA that they have worked with the reporting site regarding appropriate repair techniques. 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. Actions taken by MHRA in response to this Regulation 28 report
• 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.
• 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.

4. DETAILS OF FURTHER ACTION PROPOSED Please note that any links to webpages included in the response will not be checked for sensitive information prior to publication, as the information is already online. The MHRA is working with the manufacturer to ensure improvements to the product literature are addressed accordingly.

21 May 2026

Dear HM Senior Coroner Smith,

Following receipt of the Regulation 28: Report to Prevent Future Deaths in April 2026, University Hospitals of Leicester NHS Trust (UHL) undertook a comprehensive review of the circumstances surrounding the death of a dialysis patient following catastrophic haemorrhage caused by detachment of a haemodialysis central venous catheter (CVC) component at a DaVita-operated dialysis unit.

The incident occurred on 7 October 2025 and was immediately reported to the Coroner, the Medicines and Healthcare products Regulatory Agency (MHRA), the device manufacturer, and relevant national renal safety forums. A Patient Safety Incident Investigation (PSII) was commenced and led by DaVita, with representation from both UHL and the Lincoln renal team.

During the subsequent investigation, a second similar non-fatal incident was identified at another DaVita- operated dialysis unit. This additional event supported the conclusion that the incidents were most likely attributable to mechanical device failure rather than patient or staff actions.

A formal risk assessment has since been completed by the UHL renal service. This concluded that:
• The likelihood of recurrence is low;
• There is currently no evidence of widespread device failure either locally or nationally;
• 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.

The UHL renal team has therefore concluded that continued use of the current haemodialysis CVCs remains clinically appropriate, proportionate, and consistent with international best practice guidance, including KDOQI recommendations, provided that additional assurance and surveillance measures are maintained. The Trust is assured that the risks associated with these devices are understood, actively monitored, mitigated where possible, and subject to ongoing governance and organisational learning processes.

At the time of the incident, immediate emergency treatment was provided by dialysis staff and ambulance services. Despite these efforts, the patient sadly died shortly afterwards in hospital due to catastrophic haemorrhage.

The incident was promptly escalated through both DaVita and UHL governance systems, including RADAR and DATIX reporting mechanisms, and senior renal staff within both organisations were informed immediately. Support was offered to staff involved, and DaVita engaged with the patient’s family to understand any concerns or questions they wished to be addressed as part of the investigation process. The incident was reviewed through renal morbidity and mortality meetings and the weekly executive incident review process. DaVita convened an initial multidisciplinary meeting involving senior medical and nursing representatives from DaVita, UHL, and Lincolnshire nephrology services, following which DaVita led the formal Patient Safety Incident Investigation.

Early consideration was given to whether patient-related factors may have contributed to the incident. However, the subsequent investigation findings, together with the second similar non-fatal incident on 11 December 2025, strongly supported concerns that mechanical integrity failure of the catheter was the primary contributory factor.

The UHL Deputy Head of Nursing and Renal Matron escalated the matter to the Coroner, MHRA, the device manufacturer, the UK Kidney Association (UKKA) Patient Safety Group, and the Midlands Regional Operational Kidney Network. To date, UHL has not been informed of any specific actions undertaken by either the MHRA or the manufacturer in response to these reports.

The UKKA Patient Safety Group advised that no further similar incidents had been identified nationally despite widespread use of these catheters throughout the United Kingdom.

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.

The Regulation 28 report was further discussed at the Leicester, Leicestershire and Rutland Learning from Deaths meeting on 16 April 2026, and it was proposed that this case be presented to NHS England as an example of organisational learning relating to medical devices.

As part of the Trust’s ongoing response and learning from this incident, the following actions have been agreed:
• Development of a central electronic record of dialysis catheter type, insertion date, and insertion location across the renal network by Q3 2026;
• Updating patient information materials to include advice regarding actions to take if catheter integrity is compromised by Q2 2026;
• Updating dialysis access care plans to formally document luer-end checks and catheter details by Q2 2026;

• Implementation of three-monthly catheter site photography aligned to arteriovenous fistula surveillance processes;
• Raising issues relating to catheter longevity and device learning at national renal forums by Q3 2026;
• Continued work to reduce the proportion of patients dialysing via CVCs across the dialysis network toward the nationally recommended target of less than 20%.

These actions will continue to be monitored through the appropriate governance routes, including the Renal Board, local audit processes, morbidity and mortality review meetings, and renal nursing oversight arrangements.