BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1230365 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00518
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 26, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CALL PLACED TO HOT LINE, THAT RN COULD NOT TELL CLINICAL SUPPORT SPECIALIST (CSS) WHICH SYSTEM ERROR ALARM SHE HAD. SCREEN WAS FUNCTIONAL, HOWEVER, ONLY A PORTION OF THE NORMAL ITEMS WERE VISIBLE & EVERYTHING WAS FLASHING; PUMP WOULD NOT PUMP. CSS ASKED RN TO POWER DOWN PUMP, WAIT APPROXIMATELY 15 SECONDS & POWER BACK ON. RESULTS WERE "NO CHANGE". RN STATED PUMP WAS STILL AUDIBLY ALARMING, ALTHOUGH THEY COULD NOT VISUALLY SEE WHAT ALARM CONDITION WAS PRESENT. RN REPEATED POWER DOWN OF PUMP, WAITED APPROXIMATELY 15 SECONDS & POWERED BACK ON. RESULTS WERE SAME AS FIRST TIME. CSS STATED "WE WERE UNABLE TO STOP SYSTEM ERROR ALARM OR GET PUMP ON SO I TOLD RN TO SWITCH OUT PUMP." AT 1250PM CSS CALLED RN BACK TO CHECK ON THEIR PROGRESS & THIS TIME CSS SPOKE TO A DIFFERENT RN. PER RN, PATIENT WAS ON NEW AUTOCAT2 WAVE PUMP & EVERYTHING WAS FUNCTIONING WELL, WITH NO PROBLEMS OR QUESTIONS. CSS ASKED RN TO VERIFY SERIAL NUMBER OF FIRST PUMP & TO MAKE SURE THAT PUMP WAS FLAGGED "DO NOT USE" AND TAKEN TO BIOMED DEPARTMENT FOR FOLLOW UP.

    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