BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1203408 · Received October 17, 2008

    Report

    Report Number
    1219856-2008-00483
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 17, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WILL NOT BE RETURNED FOR EVALUATION. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO THE CLINICAL SUPPORT SPECIALIST (CSS) CALLING THE REGISTERED NURSE (RN), THE INTRA-AORTIC BALLOON PUMP (IABP) HAD ALREADY BEEN SWITCHED OUT BECAUSE IT HAD GONE THRU 2 HELIUM TANKS IN LESS THAN 3 HOURS; THE SAME PUMP HAD DONE THIS ON A PREVIOUS PATIENT. RN REMARKED THAT "EVIDENTLY, IT WAS NOT LOOKED INTO" & STATED THEY HAD NO PROBLEMS NOW. CSS EXPLAINED TO RN SEVERAL TROUBLESHOOTING POSSIBILITIES FOR FUTURE REFERENCE & THAT PUMP SHOULD GO TO BIOMED. RN SAID IT WAS THE ONLY ONE THEY HAD LEFT SO SHE WAS GOING TO CALL BIOMED TECHNICIAN THAT WAS "ON CALL" TO COME IN & CHECK IT. TECHNICIAN WAS NOT FAMILIAR WITH PUMP & AS A RESULT, CSS OFFERED TO SPEAK TO HIM DIRECTLY. CSS RECEIVED A CALL FROM TECHNICIAN WHEN HE ARRIVED AT THE HOSPITAL. HE DID NOT RELATE THAT HE HAD NEVER WORKED ON AN IABP BEFORE. CSS INSTRUCTED THE TECHNICIAN ON REMOVING TANK & LOOKING FOR O-RING. ONCE FOUND, TECHNICIAN SAID " IT DID NOT LOOK GREAT ". CSS TOLD HIM WHERE TO LOOK FOR A NEW ONE & CSS WOULD HAVE OUT FIELD SERVICE ENGINEER CALL HIM BACK & HELP HIM.

    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