BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE GERMAN

    MDR report key: 1000661 · Received February 15, 2008

    Report

    Report Number
    1219856-2008-00046
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    February 4, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT WHILE THE PT WAS IN THE INTENSIVE CARE UNIT, THE PUMP ALARMED "MULTIPLE HELIUM LOSS ALARM." THE STAFF NOTICED A CONTINUED LOSS OF HELIUM ON THE BALLOON PRESSURE WAVE. THE INTRA-AORTIC BALLOON (IAB) WAS REMOVED AND ANOTHER IAB WAS INSERTED. THE PUMP ALARMED THE SAME "MULTIPLE HELIUM LOSS ALARM" AND AS A RESULT, THE PUMP WAS EXCHANGED OFF THE PT. A THIRD PARTY SERVICE ORGANIZATION WAS INFORMED. THERE WERE NO REPORTED PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE GERMAN INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention IAB (BRAND UNK)