BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 8FR-30CC FOS

    MDR report key: 3970664 · Received June 2, 2014

    Report

    Report Number
    1219856-2014-00105
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT WHILE IN THE CATH LAB THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED VIA THE PATIENT'S RIGHT FEMORAL ARTERY. THERE WAS A CONCERN IN THE CATH LAB THAT THE PUMP (S/N (B)(4)) WAS NOT AUGMENTING PROPERLY. AS A RESULT, THE PERFUSIONIST WAS CALLED IN. THE PERFUSIONIST STATED THE AUGMENTATION WAS PROPER FOR THE PATIENT. THE PATIENT WAS MOVED TO THE CVICU. THE PERFUSIONIST WAS IN THE CARDIOVASCULAR INTENSIVE CARE UNIT (CVICU) FOR APPROXIMATELY 90 MINUTES WHAT THE PUMP ALARMED "HELIUM LOSS" AND BLOOD WAS FOUND IN THE HELIUM TUBING. THE IAB WAS REMOVED AND ANOTHER IAB WAS NOT INSERTED. THE PATIENT RECEIVED INTRA-AORTIC BALLOON PUMP (IABP) THERAPY SUCCESSFULLY FOR 2 HOURS AND 50 MINUTES. THERE WAS NO REPORTED PATIENT DEATH, INJURY OR COMPLICATIONS. THERE WAS A 10 MINUTE INTERRUPTION/DELAY IN IABP THERAPY, WHICH WAS THE TIMEFRAME FROM WHEN THE PUMP ALARMED TO THE IAB REMOVAL. PUMP STRIPS WERE NOT GENERATED, X-RAYS WERE NOT TAKEN. THE PATIENT OUTCOME IS "STILL IN CVICU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321140 IAB: 8FR-30CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. KF3055861

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR