BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 3021022 · Received March 20, 2013

    Report

    Report Number
    1219856-2013-00066
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE OPERATING THEATRE THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) VIA THE PT'S RIGHT FEMORAL ARTERY USING A SHEATH. RELEVANT MEDICAL HISTORY / DIAGNOSIS / MEDICATIONS: AVR (AORTIC VALVE REPLACEMENT) AND CABG (CORONARY ARTERY BYPASS GRAFT) - 2 GRAFTS. THE PT WAS TRANSFERRED TO THE CARDIAC CARE UNIT (CCU) AT 12:00PM AND AT 2:00PM THE PUMP (SERIAL # (B)(4)) BEGAN TO ALARM "HIGH PRESSURE." NO OBVIOUS CAUSE FOR THE HIGH PRESSURE ALARMS WAS ASCERTAINED AND THEREFORE THE PUMP WAS INITIATED AGAIN. FOR THE NEXT 10 MINS THE PUMP CONTINUED TO ALARM "HIGH PRESSURE." BLOOD WAS NOTICED IN THE TUBING AND THE PUMP WAS STOPPED AND THE IAB WAS REMOVED. THE PT WAS STABLE AT THIS TIME AND ANOTHER IAB WAS NOT INSERTED. THERE WAS NO REPORTED PT DEATH, INJURY OR COMPLICATIONS. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED. THE IAB WAS REMOVED WITH THE SHEATH AS ONE UNIT. THE PT OUTCOME IS LISTED AS STABLE IN THE INTENSIVE CARE UNIT (ICU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115474 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC KF2073667

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR INTRA-AORTIC BALLOON PUMP