BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2002505 · Received January 28, 2011

    Report

    Report Number
    1219856-2011-00033
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 24, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICAL SUPPORT SPECIALIST (CCS) THAT IN THE INTENSIVE CARE UNIT, AT 1720 EST, A CALL CAME IN REGARDING A DRAIN FAILURE ALARM. THE INTRA-AORTIC BALLOON PUMP (IABP) HAD BEEN INSERTED 72 HOURS PRIOR VIA A SHEATH AND WAS ACHIEVING THERAPY GOAL WITH NO OTHER ALARMS. THE NURSE HAD EMPTIED THE DRAIN BOTTLE WHICH WAS 1/4 FULL AND THE PATIENT WAS HAVING FREQUENT PREMATURE VENTRICULAR CONTRACTION'S (PVC) WITH THE HEART RATE OF 110 BPM. IT WAS EXPLAINED WHAT THE DRAIN TASK WAS AND WHY THIS ALARM CAN OCCUR. THE NURSE WAS INSTRUCTED TO DO A MANUAL PURGE AND TOLD THIS MAY NEED TO BE DONE A FEW TIMES AN HOUR IF THE PATIENT'S CONDITION CONTINUED. IT WAS ALSO EXPLAINED THAT THE PUMP COULD ALSO BE THE ISSUE. THE CSS CALLED BACK AT 1844 EST TO FOLLOW UP AND THE NURSE SAID THE ALARM CONTINUED AND INCREASED IN FREQUENCY. THE PUMP WAS SWITCHED AND SENT BACK TO BIOMED TO BE CHECKED. THERE WERE NO PATIENT DEATH, INJURIES OR DELAYS IN THERAPY. THE PATIENT OUTCOME WAS STABLE ON IABP THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK