BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVIDER 6000

    MDR report key: 89117 · Received May 3, 1997

    Report

    Report Number
    2024064-1997-00031
    Event Type
    Malfunction
    Date Received
    May 3, 1997
    Date of Event
    April 1, 1997
    Report Date
    April 3, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    FRN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS REC'D AND TESTED BY CO'S TECHNICAL ENGINEERING STAFF. THE PUMP POWERED ON WITH THE TOP ROW IN THE DISPLAY BLACKENED. A TEST MICROPROCESSOR WAS INSTALLED AND THE PUMP POWERED ON WITH AN INTERNAL MALFUNCTION #10. THE ORIGINAL MICROPROCESSOR WAS REINSTALLED AND THE PUMP POWERED ON WITH AND INTERNAL MALFUNCTION #11. THE NVRAM WAS THEN INITIALIZED AND THE PUMP POWERED ON NORMALLY. AN INFUSION TEST USING THE CUSTOMER'S PROTOCOL WAS PROGRAMMED AND INFUSED WITHOUT ERROR, ALARM, OR MALFUNCTION. THE PROGRAM WAS INTERMITTENT MODE, DOSE: 250ML, DOSE TIME: 1H, NUMBER OF DOSES: 1, AND TOTAL FLUID: 275ML. THE EXPECTED AMOUNT WAS 250ML AND THE MEASURED AMOUNT WAS 242.56ML. THE PERCENT OF ACCURACY WAS - 2.98%. THE KEYPAD WAS ALSO TESTED AND PASSED.

    Description of Event or Problem · 1

    DELAYED DELIVERY REPORTED. THE PUMP WAS SET TO INFUSE AN UNSPECIFIED CHEMOTHERAPY AGENT VIA SIDE A AT APPROX 150 ML/HR WITH A 275 ML CONTAINER VOLUME. THE NURSE REPORTS THAT THE PUMP STARTED WITHOUT PROBLEMS, BUT WHEN SHE CHECKED ON THE PUMP LATER, IT WAS "FROZEN". THE SCREEN WAS FROZEN AT A RECORDED DELIVERY OF 11ML, THE RUNNING ICON (THAT INDICATES DELIVERY) WAS STOPPED AND THE ROTOR WAS NOT TURNING. NO DEVICE AUDIBLE ALARM SOUNDED AND NO ALARM/ERROR MESSAGES WERE ON THE SCREEN. THE INFUSION WAS RE-STARTED ON A NEW PUMP. THE DELAYED INFUSION TIME DID NOT CAUSE ANY ADVERSE PT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVIDER 6000 INFUSION PUMP FRN ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other