BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2192824 · Received July 20, 2011

    Report

    Report Number
    1219856-2011-00254
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 14, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: PUMP WAS ON PT. SYMPTOM - LOW HELIUM TANK PRESSURE AFTER TRYING SEVERAL TANKS IN THE FIRST FLOOR CSICU (CARDIAC SURGICAL INTENSIVE CARE UNIT). THE PUMP WAS EXCHANGED FOR A SECOND PUMP DURING THE COARSE OF THERAPY DUE TO THIS ISSUE. FINDINGS/ACTIONS TAKEN: FOUND THE HELIUM TANK YOKE NOT INSTALLED PROPERLY (REVERSED). THE RN WAS INSTRUCTED FOR PROPER USE. CONFIRMED TANK PRESSURE ON THE SPARE HELIUM TANKS. SYSTEM FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. KC0108388

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK