MHRA Liaison Officer MHRA Liaison Officer Conference Conference

Shelley Dolan Chief Nurse

Royal Marsden NHS Foundation Trust

NED MHRA

Objectives of Objectives of presentationpresentation

• To present a “real” case of a medical device error in an acute trust.

• To describe the chain of events and provoke discussion

• To highlight the critical points when prevention is possible

• An organisation with a memory

The settingThe setting

• A busy Critical Care Unit

• Devices a major feature of our work

• 10 sockets on each pendant around the patient

• In the most critical situation 20 electronic devices being used simultaneously

The patientsThe patients

• The most vulnerable patients outside the Neonatal Intensive Care Unit

• Typically will have had complex major surgery / trauma / medical emergency

• They and their family receive complex intensive nursing, medical and allied health professional care.

• Care is constantly being revised, updated new therapies instituted – the aim to return the person to their pre-morbid condition…where possible.

The deviceThe device

• Could give an example of many electronic device errors

• Or disposables • Today a disposable – a multi-lumen

central venous access device.

Multi- lumen Central Multi- lumen Central Venous Access DeviceVenous Access Device

• 1 • 3

• 2 • 4

A typical CCU patient will A typical CCU patient will have multiple infusionshave multiple infusions

• Sedation• Pain control• Anticrobials• Blood• Platelets• Total Parenteral

Nutrition• Hydration• Therapeutic agents

To minimise risk of infection CVADs To minimise risk of infection CVADs changed regularly – common changed regularly – common

procedureprocedure

• Different guidelines but in CCU • Approximately every 7 days• New CVAD inserted percutaneously

asceptic procedure by doctor sometimes a nurse

• Under ultrasound guidance (NICE)• Stitched in and covered with

asceptic dressing.

Risks of CVAD insertionRisks of CVAD insertion

• Pneumothorax• Infection• Bleeding• Mechanical traumaVery rare depending on the operator

/ device / education / patient.

Seldinger techniqueSeldinger technique

Presentation of the Presentation of the error error

• Nurse Consultant and lead for Critical Care Monday 06.00 on Critical Care Unit

• Furious Intensive Care Doctor (SpR) ran into office with 5 lumen CVAD:

“ These are dangerous I don’t want to use these any more”

What had happened: Following insertion of the CVAD the wire was withdrawn but would not come out and kinked and buckled damaging the CVAD insitu.

Three attemptsThree attempts

• Very difficult to remove the CVAD• Patient unstable critically ill needing

therapies• New CVAD inserted same thing

happened.• On the other side of the patient at the

same time double lumen CVAD inserted emergency drugs and blood given.

History of Device on History of Device on CCUCCU

• Had used the same manufacturer – leading manufacturer for over 10 years

• Excellent rapport / service and products• Approximately 1 year 5 lumen catheter

previously 3 or 4 lumens• No previous problems with device reported

What actions should the NC now take?

Action taken (1)Action taken (1)• Nurse Consultant immediately quarantined

the 2 devices that had been removed from the patient.

• Identified batch numbers and took all those off the shelf – which was all 5 lumens.

• 07.00 Went down to theatres asked them to do the same

• 08.00 NC discussed with lead Anaesthetist in theatre who agreed none to be used until investigation complete.

Action (2)Action (2)

• Spoke again to SpR Anaesthetist (more calm) asked him to write a detailed statement and to complete an incident form.

• Spoke to the patient’s family explained what had happened and spent some time with them.

Action (3)Action (3)08.00 spoke to Consultant Intensivist agreed

with same, spoke to Head Nurse same agreed.09.00 rang Head of Risk Management (device

liaison coordinator), Chair of our Medical Devices Committee (NC IV Therapy)

10.00 Rang Manufacturer / Logged incident on MHRA website.

Should the NC have taken any other actions?

10.30 NC rounded up all 10.30 NC rounded up all the Junior Anaesthetists the Junior Anaesthetists

Told them about the incident

What did they say?

Over the last 3 -4 months Over the last 3 -4 months repeated incidents repeated incidents

• Minor difficulties with the guidewire seeming to snag as pulled out.

• Sometimes snagging quite badly but always removed successfully.

NONE REPORTED to ANYONE

What action should NC Take?

Action (4)Action (4)

• Urgent meeting arranged with manufacturer

• Urgent meeting with all senior and junior Anaesthetic and Intensivist staff re the importance of effective and timely incident reporting.

ResultsResults

Discussion with manufacturer revealed they had been aware of problems

New design had caused problems

MHRA investigation revealed same

New product to be launched very soon by end of 2008

The most important The most important issuesissues

• The patient was unharmed and survived to leave CCU and to go home.

• The staff of CCU more aware re incident reporting

• Good liaison with manufacturer• Good liaison with MHRA

ConclusionsConclusions

• The importance of good effective teamworking

• Always listen to colleagues • React effectively and comprehensively• Use root cause analysis • Ensure all stakeholders involved• Think widely about prevention of similar

error or repeat.• Learning across the NHS – share practice.

Thank you for listeningThank you for listening

What did we miss?

What else should we / could we have done?