Benjamin Rowley

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

Greater Lincolnshire Coroners 
Paul D Smith 
HM Senior Coroner for Greater Lincolnshire 

Re: Regulation 28 Report to Prevent Future Deaths dated 1 April 2026 

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. 

Yours sincerely, 

Sr Director, Global Quality 
Mozarc Medical

Chief Executive Office 
Level 3 Balmoral 
Leicester Royal Infirmary 
Infirmary Square  
Leicester 
LE1 5WW 

29th 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. 

Yours sincerely, 

Group Chief Executive 
University Hospitals of Leicester NHS Trust and University Hospitals of Northamptonshire NHS Group