BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD PCA PUMP

    MDR report key: 11238 · Received February 3, 1994

    Report

    Report Number
    MW1000617
    Event Type
    Malfunction
    Date Received
    February 3, 1994
    Date of Event
    December 15, 1993
    Report Date
    January 20, 1994
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PUMP WOULD NOT CHANGE LOCK LEVELS OR SELECT MODE KEY WOULD NOT WORK. NO PT PROBLEMS. THE PUMP WAS EXCHANGED. VENDOR NOTIFIED OF PROBLEM AND PUMP RETURNED FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD PCA PUMP MEA PHARMACIA DELTEC, INC. 5800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *