Leslie Matthews

Date of report	26 Jul 2016
Reference	2016-0276
Deceased	Leslie Matthews
Coroner	Crispin Oliver
Coroner area	County Durham and Darlington
Category	Hospital Death (Clinical Procedures and medical management) related deaths · Other related deaths
Source	judiciary.uk record · original PDF
Responses published	2

The report

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Responses

2 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.

Response from County Durham and Darlington NHS Trust (PDF)

County Durham and Darlington INHS|

NHS Foundation Trust

Executive Corridor
Darlington Memorial Hospital
Hollyhurst Road

Darlington, DL3 GHX

Your Ref
Our Ref:
16" September 2016

Crispin A Oliver M.A.
HM Assistant Coroner
H.M Coroners Office
PO Box 282

Bishop Auckland

Go Durham

DL14 4FY

Dear Mr Oliver

| am writing in response to the Regulation 28 letter issued on 1 August 2016. The content of the
Regulation 28 letter has been given due consideration and an action plan put in place to reduce any
risk of future harm from a similar incident to patients in our care.

Mr Matthews was a gentleman who died from an infective exacerbation of chronic obstructive
pulmonary disease on 19 February 2016. A concern was raised regarding equipment failure
potentially contributing to the cause of death. An oxygen flowmeter had suffered a crack and was
defective.

| have discussed the Regulation 28 with the Head of Clinical Engineering for the Trust and he has
provided further clarity as follows:

The Flowmeter found to be damaged waas still in use by the ward staff. However the flowmeter
still delivered Oxygen but at an undefined rate due to the small crack in the plastic outer tube
of the flowmeter body. Under pressure of the supply gas (nominal 4 bar, O2) it is reasonable to
assume the gas escaping to atmosphere via the crack was variable and hence related to the
flow setting on the device caused by any back pressure level. Noise associated with the
damage/leaking of 02 gas would most likely be evident to the user when operating the device
but again probably related to the flow setting on the device itself.

The actual crack damage would not get worse due to increased flow as such, but rather the
gas ‘lost’ to atmosphere would increase by escaping through the crack in the outer tube.

www.cddft.nhs.uk
Chief Executive. Darlington Memorial Hospital, Hollyhurst Roact,
Darlington, County Durham DL3 6HX

Aena 3u} jje 4 noA uM

County Durham and Darlington Wi

NHS Foundation Trust

Overall maximum pressure within the flowmeter is limited to the supply gas pressure from the
wall outlet (nominal 4 bar = 60PSI approx.).

Equipment suspected of damage should not be used. It should be removed from use, reported
and a replacement device, in good condition, substituted. This is part of national and Trust
policy. This issue is clearly documented in issued guidance from MHRA/DoH.

The O; flowmeter device in question is a very simple device with one mechanical moving part
(on/off flow knob). Everything else is sealed by design and in normal conditions the flow
indicator is proportional to the gas flow being set with the flow knob by the clinical user.
Oxygen is a drug and administered accordingly.

In good condition these devices last for many years and are unlikely to fail due to natural
component degradation. They require no planned technical intervention other than basic in-
use functional checks by users. Damage is rectified by technical repair or replacement once
the device is reported as defective. Replacement would normally be planned ‘as required’ by
the users as a small value item (typically £60-£90), or following major damage that renders a
repair uneconomical. All these devices work in the same way from the control knob action
(anti-clockwise for ‘ON’ and flow increase versus clockwise for decreased flow and ‘OFF’)

Following review of this incident | can confirm that the damage report was not confined to within the
Trust and | apologise that this information was not fully shared with you at the time. The incident was
reported to the Adverse Incident Centre at MHRA and they asked the manufacturer to investigate our
report of damage. The manufacturer responded to our report and MHRA responded to the Trust on 25
May 2016, and stated that they found the manufacturer response acceptable and that they had closed
the incident, as follows:

MHRA —_—
Your Ref.

Thank you for your report in connection with the following:
Device: Flowmeter, Manufacturer: Oxylitre Ltd

We asked the manufacturer to investigate your report. Their response is as follows:

"We found that there was a crack in the outer tube of one of the twin
flowmeters. When plugged into a gas source with the control knob turned off,
the bobbin (which indicates flow) is positioned at the top of the inner tube.
When turned on the flowmeter would still supply the maximum flow rate. The
customer indicated they noticed the crack when tuming off the flowmeter, so
regardless of the crack the flowmeter was continuing to supply oxygen. The
crack in the top of flowmeter outer tube (approximately 30mm in length) was
likely to have occurred by an impact. As soon as the unit is plugged into an
Oxygen Terminal it would have been immediately obvious that it was leaking
through the crack due to the very audible sound. Therefore we do not understand
how clinical staff would deliberately use a defective unit. However, it is

www.cddft.nhs.uk
Chief Executive. Darlington Memorial Hospital, Hollyhurst Road,
Darlington, County Durham DL3 6HX

Aem au} |e ¢ noA uM

County Durham and Darlington NHS)

NHS Foundation Trust

possible that the damage occurred whilst in use, but as indicated the device
would still deliver Oxygen. Note Oxygen tube fitting is missing from the base
of the other flowmeter.

The returned unit is 15 years old. We could replace the cracked outer tube as a
repair, but we do not support items that are over 10 years old and would
normally offer a service exchange device. This has been indicated to the person
who reported the incident as of 25.4.16. There is no other particular action
Oxylitre can take since there is no design fault or any other problem with this
mode! of device.

We have no idea how this item could be associated with the death of a patient. As indicated, it
would still supply Oxygen to a patient regardless of the damage found. Also as indicated we
cannot understand how an obviously faulty device would be used in a clinical environment to
administer Oxygen fo a patient. We can only conclude that because there is a link; however
tentative, to a patient's death an adverse incident was raised regardless if there was zero
contribution due to the damaged item."

We (MHRA) have reviewed the manufacturer’s conclusions and consider them acceptable so
we won't investigate any further.

You raised concerns that none of the information provided by the Trust has addressed the audible
indication of damage to the device, and the fact that it was not detected by that means. A medical
devices newsletter was circulated in April which outlined that the MHRA (2015) advises routine
maintenance ensuring that the device continues to function correctly. It may include regular inspection
and care, as recommended in the manufacturer's user information or Trust policy.

Tasks may include:

e Checking that devices work correctly before use

e Regular cleaning

« Specific daily, weekly checks

¢ Noting when a device has stopped working properly or when obvious damage has occurred,
and then discontinuing use

e Contacting the relevant servicing organisation

Also included in the message was a reference to audible evidence of a gas leak from the device;
‘when this type of damage occurs, staff may hear a hissing sound of the gas escaping when in use
and see visible damage’.

Medical Devices
Newsletter Issue 20 /

www.cddft.nhs.uk
Chief Executive. Darlington Memorial Hospital, Hollyhurst Road,
Darlington, County Durham DL3 6HX

Aem au} |je ¢ noA yyM

County Durham and Darlington INHS|

NHS Foundation Trust

| have ensured that this issue has been raised at the Senior Nurse Leadership Group and all Care
Group Governance Meetings within the organisation. All Associate Directors of Nursing have
discussed this with clinical staff in all departments to reinforce the importance of checking oxygen
flowmeters which includes any detection of audible hissing indicating a leaking of gas from the device.

Actions

1. All oxygen flowmeters across the Trust have been checked by the Clinical Engineering
Department and any faults logged and reported to Department Managers

All Equipment Controllers/Department Managers to perform a full weekly check of all their
flowmeters and report any damage to their local Clinical Engineering departments. A checklist has
been devised by the Medical Devices Nurse and will be discussed at the next meeting of the
National Association of Medical and Educational Trainers (NANDET) (next meeting 21/09/16)
before being utilised across the organisation.

trey
Medical Gas
Flowmeter checklist d
| hope the response addresses the concerns raised and provides assurance of the processes that

have been put in place to prevent recurrence of this issue

Yours Sincerely

SoS SD

Sue Jacques
CHIEF EXECUTIVE

www.cddft.nhs.uk
Chief Executive. Darlington Memorial Hospital, Hollyhurst Road,
Darlington, County Durham DL3 6HX

Aem au} je 4 noA uM

Response from Medicines and Healthcare Products Regulatory Agency (PDF)

Medicines and Healthcare
Products Regulatory Agency
eee

151 Buckingham Palace Road
London SW1W 9SZ
United Kingdom

mhra.gov.uk

Crispin A Oliver, H M Assistant Coroner for County Durham and
Darlington

H.M. Coroners Office

PO Box 282

Bishop Auckland

Co Durham

DL14 4FY

15 August 2016
MHRA Ref: 2016/004/012/291/010
RE: Lesiie Matthews deceased

Medical Device: oxygen flowmeter

Manufacturer: Oxylitre

Model: F1602

Serial Number: 01729xxx (only a partial number is available due to label damage)

Dear Mr Oliver,
| write with reference to your letter of 1 August 2016.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an Executive Agency of the Department of
Health. The aim of the MHRA Devices Division is to take all reasonable steps to protect public health and
safeguard the interests of patients and users by ensuring that medical devices meet appropriate standards of
safety, quality and performance and that they comply with the relevant Directives of the European Union.

The MHRA liaises with manufacturers to ensure that their products are as safe as reasonably possible, and that all
information necessary to allow the device to be used correctly and safely is provided. Where required, we also take
appropriate action with manufacturers and issue advice to users as a result of our investigations into adverse
incidents.

Synopsis of incident detalis

Mr Matthews died from an infective exacerbation of Chronic Obstructive Pulmonary Disease on 19 February 2016.
He was receiving oxygen at the time of his death, with an Oxylitre flowmeter used to regulate and measure oxygen
flowrate. The flowmeter was later found to be damaged.

The forensic post mortem autopsy concluded that the reduced oxygen flow emanating from the damaged flowmeter
did not significantly contribute to his death.

On the 1 August 2016, you contacted the MHRA requesting that we look into whether MHRA action could be taken
to prevent future deaths. Your main concerns regarded a lack of clarity and completeness of guidance relating to
pre-use checks and general maintenance of flowmeters.

Medicines and Healthcare
Products Regulatory Agency
oee
Device Description

The Oxylitre F1602 flowmeter is a device used to measure the flow rate of therapeutic oxygen administered to
patients. It is designed to measure oxygen flow rate from 0 — 15 l/min. The device comprises of a chrome-plated
brass body with BS (British Standard) probe and an outer tube used to keep the unit “gas tight" (appendix 1).

Manufacturer's investigation

On 12 April 2016 MHRA received an adverse incident report from FY Head of Non-Clinical Risk
Management at Darlington Memorial Hospital (Hollyhurst Road, Darlington DL3 6HX). The hospital's report stated
“Crack in flowmeter tube causing O; leak of indeterminate volume. Device was reported as ‘unable to turn off”.
Following receipt of the incident report received on 13/04/16, MHRA requested that Oxylitre investigate the event.

On 9 August 2016 MHRA were advised by Oxylitre that they had inspected and tested the F1602 flowmeter to
determine whether oxygen flow had been compromised.

Oxylitre noted that a noticeable crack was visible in the outer tube (appendix 2). Upon testing, the manufacturer
identified that when plugged into a gas source the flowmeter supplied oxygen at the maximum flow rate (15 l/min).
Therefore, the manufacturer's analysis concluded that the device was still capable of supplying sufficient oxygen to
the patient. MHRA did not witness the manufacturer's examination of the F1602 flowmeter, but has reviewed the
manufacturer's report (appendix 3).

The particular unit in question is approximately 15 years old (exact date of manufacture cannot be established as
serial number has been partially removed — appendix 2).The manufacturer has confirmed that the device had
exceeded the recommended service life of 10 years. According to your report, a review by the clinical engineering
department of Oxylitre flowmeters in use at Darlington Memorial Hospital found that a further 2 devices available for
use were cracked.

MHRA analysis of instructions for use (iFU)
Oxylitre provided MHRA with a copy of the IFU for the F1602 flowmeter (appendix 4).

The IFU states “No leaks are permissible on the device’, and advises the user to visually check the device for
cracks before use. A user who identifies a crack should discard the product prior to patient use.

It would appear that the hospital had not performed pre-use checks in line with the manufacturer's IFU.

The IFU states that, only qualified servicing personnel should perform tests to detect leaks, therefore implying that
additional specific instructions referring to pre-use leak tests are unnecessary.

We have undertaken a comparative assessment of various manufacturers’ IFUs for similar devices to determine
whether there are any insufficiencies in the pre-use checks description for the Oxylitre flowmeter. The information
collected indicates that the Oxylitre IFU provides sufficient guidance for the user to perform pre-use checks and is
in line with alternative products. Although the IFU appears sufficient, we have forwarded your concerns regarding
clarity and completeness of guidance to Oxylitre for their consideration in their next revision.

Additional Guidance

General guidance can be found in the MHRA's publication Managing Medical Devices (appendix 5). The purpose of
this document is to outline a systematic approach to the acquisition, deployment, maintenance, repair and disposal
of all medical devices. It is intended primarily for people in hospital and community based organisations who are
responsible for the management of reusable medical devices to help them promote safe and effective use of
medical devices. The document, which can be applied to oxygen flowmeters, states that a healthcare
organisation's medical device management policy must cover the provision of maintenance and repair of all

Medicines and Healthcare
Products Regulatory Agency
ece

medical devices, including reconditioning and refurbishment. The healthcare organisation is responsible for
ensuring their medical devices are maintained appropriately.

Similar reports received by MHRA

Oxylitre have confirmed that no similar incidents or complaints regarding the F1602 flowmeter have been reported
to them. A review of the MHRA’s adverse incident database has shown that since 2006 we have received no
adverse incident reports involving cracked flowmeters.

Conciusion
The MHRA received an adverse incident report concerning a cracked flowmeter which was in use by a patient who
subsequently died.

The manufacturer's investigation identified that the cracked flowmeter was still capable of supplying oxygen at the
maximum flowrate.

The manufacturer of the oxygen flowmeter is fully compliant with the Medical Device Directive 93/42 EEC, and the
device was functional despite exceeding the manufacturer's recommended service life.

The MHRA has not identified a systemic problem with cracks associated to Oxylitre flowmeter. The manufacturer's
Instructions for Use appear sufficient including details of pre-use inspection. The MHRA has brought the Coroner's
concerns to the attention of the manufacturer. We have also requested that the manufacturer evaluate whether
additional clarity in information could be incorporated at the next Instructions for Use review.

The MHRA is continuing to monitor this situation and will investigate any further incidents that we receive

If the MHRA can be of any further assistance in this matter, please contact us.

Yours sincerely,
Ce Een
AO Wea

Dr lan Hudson
Chief Executive Officer

The report

Responses

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