BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB: 7.5 FR - 40 CC

    MDR report key: 4240036 · Received November 3, 2014

    Report

    Report Number
    1219856-2014-00204
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 23, 2014
    Report Date
    October 23, 2014
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K000729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE INTRA-AORTIC BALLOON (IABP) WAS PREPPED AND INSERTED VIA THE PT'S LEFT FEMORAL ARTERY. AFTER PLACEMENT OF THE IAB THE PUMP (S/N (B)(4)) ALARMED "LARGE HELIUM LEAKAGE". AT THIS TIME, THE IAB WAS REMOVED AND A NEW IAB WAS PREPPED AND INSERTED IN THE SAME INSERTION SITE. THERE WAS NO REPORTED PT DEATH, INJURY OR COMPLICATIONS. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS A 1/2 HOUR DELAY / INTERRUPTION IN INTRA-AORTIC BALLOON PUMP (IABP) THERAPY. THE PT OUTCOME IS LISTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704051 IAB: 7.5 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. KF3055905

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR