BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE JAPANESE

    MDR report key: 2171443 · Received June 30, 2011

    Report

    Report Number
    1219856-2011-00237
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 22, 2011
    Report Date
    June 30, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTROL NO (B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. AFTER TWO DAYS OF PUMPING WITH A COMPETITOR'S DATASCOPE YAMATO 35CC INSERTED VIA LEFT FEMORAL ARTERY AND AN ARROW AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP, THE PUMP ALARMED "SYSTEM ERROR 3" (SUBCODE: 5, CPU-PUMP SERIAL COMMUNICATION FAILURE) AND THEN THE PUMP STOPPED. CORRECTION ACTIONS INCLUDED ALARM RESET, PRESSING PUMP ON AND TURNING POWER OFF THEN ON AGAIN, WERE DONE. THE PUMP STILL GAVE THE SAME ALARM. AS A RESULT, THE PUMP WAS EXCHANGED WITH SUCCESS AND THE THERAPY CONTINUED. NO MEDICAL/SURGICAL INTERVENTION WAS NEEDED. THERE WAS NO DELAY OR INTERRUPTION IN THERAPY. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. THE PATIENT'S OUTCOME IS GOOD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK