BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 370287 · Received January 3, 2002

    Report

    Report Number
    370287
    Event Type
    Death
    Date Received
    January 3, 2002
    Date of Event
    September 6, 2001
    Report Date
    October 18, 2001
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS DIVISION
    Product Code
    DWE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    DURING THE TRANSFER OF A PT FROM AN OPERATING ROOM TABLE TO A ICU BED, FOAM WAS OBSERVED IN THE ECMO PUMP RACEWAY TUBING AND AIR WAS SEEN IN THE ARTERIAL AND VENOUS CANNULA. NO ONE NOTICED THAT WHILE THE ECMO CONSOLE WAS BEING MOVED, THE ARTERIAL CIRCUIT TUBING HAD BECOME TANGLED IN THE WHEEL AND A DRUG PORT WAS PUSHED OPEN (MOST LIKELY BY THE SAME WHEEL). BECAUSE THE TUBING EXITING THE VENOUS RETURN MONITOR (VRM) WAS TWISTED, (OCCLUDING BLOOD FLOW) THIS MAINTAINED ENOUGH BACKPRESSURE TO SATISFY THE VRM, PREVENTING IT FROM ALARMING AND STOPPING THE PUMP. AT THE SAME TIME, THE BUBBLE DETECTOR SENSOR WAS BEING SERVICED AND ITS ALARM HAD BEEN DISABLED. THE COMBINATION OF EVENTS PREVENTED ANY ALARM FROM SOUNDING AND SIMULTANEOUSLY ALLOWED AIR TO BE SUCKED INTO THE ARTERIAL SIDE OF THE CIRCUIT PT. AIR WAS PUMPED INTO THE PT'S HEART AND THEY DEVELOPED A FATAL ARRHYTHMIA AND ARRESTED. ATTEMPTS AT RESUSCITATION WERE UNSUCCESSFUL. TESTING OF THE ECMO EQUIPMENT HAS CONFIRMED THAT IT DID NOT MALFUNCTION. THE DISPOSABLE CIRCUIT HAD BEEN DISPOSED OF AND WAS NOT EXAMINED, BUT THERE IS NO INDICATION OF A PROBLEM WITH THE CIRCUIT. THE CAUSE OF THE INCIDENT IS BELIEVED TO BE HUMAN ERROR. THE AUTOPSY REPORT STATES THAT AIR WAS SEEN AND FELT IN BOTH HEART CHAMBERS AND REPORT ALSO LISTS THE CAUSE OF DEATH AS AIR EMBOLI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ECMO CIRCUIT DWE MEDTRONIC PERFUSION SYSTEMS DIVISION * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO Death SHILEY ECMO PUMP