BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2

    MDR report key: 2152783 · Received July 3, 2011

    Report

    Report Number
    2152783
    Event Type
    Malfunction
    Date Received
    July 3, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 3, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT CONCERNS EQUIPMENT MALFUNCTION DURING A (B) (6) PATIENT TRANSPORT. THE INCIDENT OCCURRED AT THE BEDSIDE IN THE CARDIAC/SURGICAL ICU AT AN OUT SIDE HOSPITAL. THE PATIENT HAD AN INTRA-AORTIC BALLOON PUMP (IABP) IN PLACE. THE PATIENT HAD BEEN SUCCESSFULLY TRANSITIONED FROM THE UNIT'S IABP TO THE TRANSPORT IABP. IT HAD BEEN RUNNING NORMALLY FOR APPROXIMATELY 90 MINUTES WHEN THE DISPLAY SCREEN WENT BLANK ON THE TRANSPORT IABP. SHORTLY AFTER, A BURNING ODOR WAS NOTICED. THE LOWER RIGHT PART OF THE SCREEN BECAME WARM TO THE TOUCH AND BEGAN TO DISCOLOR. THE SCREEN WAS THEN UNPLUGGED. THE IABP CONTINUED TO PUMP. THE PATIENT WAS PLACED BACK ON THE HOME UNIT IABP. A SECOND IABP WAS FLOWN FROM OUR HOSPITAL. THE PATIENT WAS PLACED ON THE REPLACEMENT TRANSPORT IABP SUCCESSFULLY, AND THE TRANSPORT WAS COMPLETED TO THE HOSPITAL. AT NO TIME DID THE PATIENT HAVE A DROP IN BLOOD PRESSURE OR CARDIAC OUTPUT. THERE IS NO SERVICE BULLETIN FROM ARROW; THEY ISSUED A TECH TIP "DISPLAY HEAD LOCKNUT IMPROVEMENT" DOCUMENT. I THINK THIS SHOULD BE A CORRECTIVE ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 PUMP, INTRA-AORTIC BALLOON, AIR TRANSPORT DSP ARROW INTERNATIONAL, INC. AUTOCAT2 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *