BEUDAMED
    FDA Adverse Event Death Summary report: N

    560 BIO-CONSOLE BASE UNIT

    MDR report key: 2231459 · Received August 25, 2011

    Report

    Report Number
    2184009-2011-00046
    Event Type
    Death
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    MEDTRONIC PERFUSION SYSTEMS
    Product Code
    DWA
    PMA / PMN Number
    K070286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), EVAL METHOD: DEVICE EVENT LOG REVIEWED. ANALYSIS: THE INSTRUMENT WAS NOT RETURNED. ANALYSIS OF THE EVENT LOG DATA VERIFIED THAT THE INSTRUMENT OPERATED AS DESIGNED AS PER THE OPERATOR'S MANUAL WITH NO ERRORS. THE EVENT WAS NO TREATED TO DEVICE PERFORMANCE. NO ADD'L ACTION TO BE TAKEN. CONCLUSION: BASED ON THE INFO PROVIDED, THE ALARMS PERFORMED AS INTENDED AND NO DEVICE MALFUNCTION WAS IDENTIFIED. THE REPORTED EVENT IDENTIFIED USER ERROR AS A CONTRIBUTING FACTOR IN THE PT'S DEATH.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFO THAT THIS PT WHO WAS IN THEIR (B)(6) WAS ADMITTED TO THE HOSPITAL IN A COMA DUE TO AN ACUTE MYOCARDIAL INFARCTION. PERCUTANEOUS CARDIOPULMONARY SUPPORT (PCPS) WAS IMPLEMENTED USING A BIO-CONSOLE. IT WAS REPORTED THAT AN ALARM OF THE BIO-CONSOLE NOTIFIED THAT AN AC CORD WAS OFF. IT WAS NOT IMMEDIATELY IDENTIFIED WHICH DEVICE WAS CAUSING THE ALARM AND NO RESPONSE WAS PROVIDED TO THE ALARM. THIRTY MINUTES LATER, THE BIO-CONSOLE ACTIVATED ANOTHER ALERT WITH THE MESSAGE, "LOW BATTERY". AGAIN, THERE WAS NO RESPONSE TO THE ALERT AND THE BATTERY DEPLETED AND THE DEVICE STOPPED. CARDIAC MASSAGE WAS INITIATED AND DURING THIS TIME, IT WAS FOUND THAT THE EXTENSION CORD TO WHICH THE AC CORD OF THE BIOCONSOLE WAS ATTACHED, WAS ALMOST UNPLUGGED FROM THE WALL SOCKET. IT WAS PLUGGED IN PROPERLY, BUT THE BIO-CONSOLE DID NOT ACTIVATE, SUBSEQUENTLY, THE HAND CRANK WAS USED FOR 20 MINUTES. THE BIO-CONSOLE WAS THEN ACTIVATED, BUT THE PT COULD NOT BE RESUSCITATED. THE REPORTED CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE. THE HOSPITAL REPORTED THERE WAS NO DEVICE MALFUNCTION, BUT RATHER USER ERROR. THE DEVICE WILL NOT BE RETURNED. HOWEVER, THE DOWNLOADED LOG FROM THE DEVICE WILL BE SENT TO THE U.S FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 560 BIO-CONSOLE BASE UNIT DWA MEDTRONIC PERFUSION SYSTEMS 560B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death