BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 1203520 · Received October 17, 2008

    Report

    Report Number
    1219856-2008-00481
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 13, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 1303 HRS., WHILE IN THE OPERATING ROOM, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION AND INSERTED AFTER "CPB WEANING PROBLEMS RECAB." MD REPORTED THERE WERE "SOME FIBEROPTIX SENSOR FAILURES IN THE BEGINNING, BUT SOLVED LATER ON. PUMP ALARMS - LOW LIGHT, CAL KEY, PRESSURE LIMIT." PATIENT (PT.) WAS SENT TO INTENSIVE CARE UNIT "AROUND 1400 HOURS" AND WAS "ACCEPTABLE AND STABLE WITH INTRA-AORTIC BALLOON PUMP SUPPORT." MD STATED "AROUND 1830 HRS. PT. COLLAPSED, HEMODYNAMIC WITHIN A MINUTE AND PERSONNEL IN INTENSIVE CARE UNIT HAD TO DO CPR." PT'S THORAX WAS OPEN AND MD SAW A "BIG RIGHT SWOLLEN HEART - CVP RAISED UP FROM 12 TO HIGH LEVELS IN A MINUTE." DURING CPR "BLOOD WAS FOUND IN IAB SHAFT AND PUMP ALARMED 'BLOOD IN LINE' AND STOPPED PUMPING." A CLAMP WAS PLACED ON IAB TUBING TO AVOID BLOOD FROM GETTING INTO PUMP. PT. EXPIRED "AROUND 1900 HOURS, DUE TO TOTAL RIGHT HEART FAILURE." X-RAYS WERE PERFORMED - "40CC IAB AND 7CM TOO LOW - REPOSITIONED 1400 HOURS IN ICU." MD'S OPINION IS "THE PATIENT DID NOT EXPIRE DUE TO IAB LEAK; PT. HAD A TOTAL HEART FAILURE." TELEFLEX HOLLAND WILL CHECK PUMP. STRIPS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death INTRA-AORTIC BALLOON PUMP (BRAND UNKNOWN)