BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCA

    MDR report key: 224024 · Received May 18, 1999

    Report

    Report Number
    224024
    Event Type
    Malfunction
    Date Received
    May 18, 1999
    Date of Event
    April 15, 1999
    Report Date
    May 18, 1999
    Manufacturer
    ABBOTT LABS - HPD
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DIAGNOSIS TAH; ABBOTT PCA PUMP PROGRAMMED TO DELIVER A DEMEROL CONCENTRATION OF 10MG ML; DEMEROL MFG BY ABBOTT; PUMP SETTING WAS 100 MG Q 3 HR PRN; 15 MG/HR CONTINUOUS; PUMP SOUNDED OCCLUSION ALARM; OCCLUSION CLEARED; PUMPED TURNED OFF; PUMP TURNED BACK ON AND REPROGRAMMED; PUMP STARTED; PUMP ADMINISTERED WRONG DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA PAIN CONTROL ANALGESIA PUMP MEA ABBOTT LABS - HPD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other