BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE JAPANESE

    MDR report key: 1170255 · Received September 11, 2008

    Report

    Report Number
    1219856-2008-00433
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 9, 2008
    Report Date
    September 11, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE IN THE PATIENT, THE INTRA-AORTIC BALLOON (IAB) VOLUME RECOGNITION ON THE PUMP WAS 12CC, EVEN THOUGH THE IAB IN USE WAS A 30CC MANUFACTURED BY TOKAI MEDICAL. THE IAB WAS PUMPING WITHOUT PROBLEMS OR ALARMS, BUT THE PATIENT'S BLOOD PRESSURE HAD DECREASED SLIGHTLY. THE CONNECTION BETWEEN THE CATHETER AND THE PUMP WAS STABLE AND FIRM. THE PUMP WAS THE SUSPECTED PROBLEM AND AS A RESULT, WAS EXCHANGED TO ANOTHER PUMP. THE PUMP WAS EXAMINED BY THE USERS TECHNICAL STAFF, BUT THE ISSUE COULD NOT BE DUPLICATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR INTRA-AOTIC BALLOON| TOKAI MEDICAL