MHRA Liaison Officer Conference Shelley Dolan Chief Nurse Royal Marsden NHS Foundation Trust NED MHRA

Objectives of presentation 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 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 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 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 Venous Access Device

A typical CCU patient will have multiple infusions Sedation Pain control Anticrobials Blood Platelets Total Parenteral Nutrition Hydration Therapeutic agents

To minimise risk of infection CVADs changed regularly – common procedure 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 insertion Pneumothorax Infection Bleeding Mechanical trauma Very rare depending on the operator / device / education / patient.

Seldinger technique

Presentation of the error Nurse Consultant and lead for Critical Care Monday 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These are dangerous I don’t want to use these any more” What had happened: Following insertion of the CVAD the wire was withdrawn but would not come out and kinked and buckled damaging the CVAD insitu.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 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 CCU 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) 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 Went down to theatres asked them to do the same NC discussed with lead Anaesthetist in theatre who agreed none to be used until investigation complete.

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) spoke to Consultant Intensivist agreed with same, spoke to Head Nurse same agreed rang Head of Risk Management (device liaison coordinator), Chair of our Medical Devices Committee (NC IV Therapy) Rang Manufacturer / Logged incident on MHRA website. Should the NC have taken any other actions?

10.30 NC rounded up all the Junior Anaesthetists Told them about the incident What did they say?

Over the last 3 -4 months 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) 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.

Results 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 issues 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

Conclusions 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 listening What did we miss? What else should we / could we have done?