BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8FR - 40 CC

    MDR report key: 1419465 · Received April 9, 2009

    Report

    Report Number
    1219856-2009-00163
    Event Type
    Malfunction
    Date Received
    April 9, 2009
    Date of Event
    March 2, 2009
    Report Date
    April 9, 2009
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRUGS/CONCENTRATIONS ADMINISTERED WERE "THE PROPER DRUGS FOR PRIMARY PERCUTANEOUS CORONARY INTERVENTION (PPCI) - VFM, ADDITIONALLY ADRENALINE, DOPAMINE, REO-PRO." AFTER RESTORING THE ARTERIAL PATENCY [DOMINANT CX] AND DUE TO PERSISTANT HYPOTONIA, PHYSICIAN DECIDED TO INSERT THE INTRA-AORTIC BALLOON (IAB). AFTER THE LEFT FEMORAL ARTERY WAS ACCESSED, THE IAB WAS PASSED THROUGH THE SHEATH INTO ARTERY. AFTER THE CONNECTION, IAB TO THE IAB PUMP (ACAT 1 PLUS, (B) (4)), THE WARNING MESSAGE "HELIUM LEAK" APPEARED. AS A RESULT, THE IAB WAS REMOVED AND "BLOOD MARKS INSIDE THE BALLOON WERE VISIBLE." THE MD INSERTED A IAB-S840U, LOT NUMBER MF8103568, (B) (4). THE PT IS IN SATISFACTORY CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. MF8103571

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR ADRENALINE| REO-PRO| DOPAMINE| ACAT 1 PLUS BALLOON PUMP