BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 316640 · Received February 13, 2001

    Report

    Report Number
    2921482-2001-00055
    Event Type
    Other
    Date Received
    February 13, 2001
    Date of Event
    January 19, 2001
    Report Date
    January 19, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF A PROGRAMMING ERROR IN PAIN MANAGEMENT THERAPY. IT WAS REPORTED THAT THE PT WAS RECEIVING PAIN MANAGEMENT THERAPY WITH MORPHINE SULFATE. THE PUMP WAS PROGRAMMED WITH A DRUG CONCENTRATION OF 1MG/1ML, BUT THE VIAL THAT WAS USED IN THE PUMP WAS A 5MG/1ML VIAL. THERE WAS NO REPORTED ADVERSE PT EVENT. IT WAS REPORTED THAT THERE WAS NO EFFECT TO THE PT AND THAT NO MEDICAL INTERVENTIONS WERE NEEDED FOR THE PT. THOUGH REQUESTED, NO FURTHER INFORMATION WAS AVAILABLE AS TO THE PUMP SETTINGS, AMOUNT OF MEDICATION THE PT ACTUALLY RECEIVED OR ANY PT SPECIFIC INFORMATION. THE PUMP WILL NOT BE RETURNED FOR TESTING AND INVESTIGATION, AS IT HAS BEEN PLACED BACK INTO CLINICAL SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5592 LIFECARE PCA PLUS INFUSER INFUSION PUMP MEA ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other