BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2507818 · Received March 23, 2012

    Report

    Report Number
    1219856-2012-00112
    Event Type
    Malfunction
    Date Received
    March 23, 2012
    Date of Event
    March 2, 2012
    Report Date
    March 23, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT (ICU). THE MD INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA LEFT FEMORAL ARTERY AT APPROX 20:00 HOURS. HOURS LATER THE PUMP BEGAN ALARMING "HELIUM LOSS." THE NURSE OBSERVED BLOOD IN THE HELIUM SUPPLY LINE. AS A RESULT, THE IAB AND SHEATH WERE REMOVED SUCCESSFULLY. WHILE THE MD WAS REMOVING THE IAB, IT WAS OBSERVED THAT THE IAB HAD RUPTURED. THE MD MADE THE DECISION NOT TO INSERT ANOTHER IAB BECAUSE THE PT WAS STABLE. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS AN UNK TIME OF DELAY OR INTERVENTION IN THERAPY NOTED WITH NO HARM TO THE PT. THE PT OUTCOME IS THE PT IS HEMODYNAMICALLY STABLE ON CURRENT MEDICATIONS.

    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 UNK INTRA-AORTIC BALLOON PUMP