BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROVIDER IV PUMP

    MDR report key: 15238 · Received August 15, 1994

    Report

    Report Number
    MW1003090
    Event Type
    Malfunction
    Date Received
    August 15, 1994
    Date of Event
    August 11, 1994
    Report Date
    August 12, 1994
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING MORPHINE SULFATE PCA WITH PUMP. NEW CASSETTE PLACED ON PUMP 8/7/94. SINCE THAT TIME PT EXPERIENCED INCREASED PAIN, REQUIRING MULTIPLE INCREASES IN RATE. RN WENT TO PT'S HOME ON THE EVENING OF 8/11 EXPECTING TO CHANGE EMPTY BAG. FOUND BAG TO BE NEARLY FULL. NEW CASSETTE USED WITH SUBSEQUENT PAIN RELIEF. PUMP SEEMS TO BE FUNCTIONING PROPERLY WITH THE PRIMARY VARIABLE BEING THE CASSETTE IN QUESTION. MFR RECENTLY REDESIGNED THIS TYPE CASSETTE BUT OLD STOCK IS BEING DEPLETED (CASSETTE IN QUESTION WAS OLD MODEL.) PT EXPERIENCED INADEQUATE PAIN RELIEF ON CASSETTE IN QUESTION. WHEN NEW CASSETTE WAS USED PT EXPERIENCED RELIEF. PUMP PROGRAM HAS BEEN VERIFIED AS CORRECT. PUMP WAS RUNNING (NOT TURNED OFF) AT TIME OF INCIDENT. EXPERIENCED A SIMILAR EVENT ON 7/19/94 WITH A DIFFERENT PT ON A DIFFERENT PUMP. CASSETTE IN QUESTION TURNED OVER TO MFR FOR ANALYSIS. ALSO SEE 1003091.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROVIDER IV PUMP MEA ABBOTT LABORATORIES 5500

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other PT RECEIVED CHEMOTHERAPY TREATMENT 2 WEEKS AGO