BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 228896 · Received June 18, 1999

    Report

    Report Number
    2921482-1999-00105
    Event Type
    Other
    Date Received
    June 18, 1999
    Date of Event
    May 1, 1999
    Report Date
    May 19, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    MEA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF TWO SEPARATE INCIDENTS OF OPERATOR ERROR INVOLVING PROGRAMMING OF THE DRUG CONCENTRATION. THE HOSPITAL HAS RECENTLY ADDED THE 5 MG/ML MORPHINE VIAL TO THEIR STOCK. THEY USED TO USE JUST THE 1MG/ML VIAL. CUSTOMER RISK MANAGER STATES THAT ON TWO SEPARATE OCCASIONS THEY HAVE HAD TWO DIFFERENT, EXPERIENCED NURSES INADVERTENTLY PROGRAM THE PUMP FOR A 1MG/ML CONCENTRATION WHEN A 5MG/ML VIAL WAS IN USE RESULTING IN OVERDELIVERY OF MORPHINE. BOTH PTS REPORTEDLY DID NOT EXPERIENCE ANY ADVERSE EFFECTS. "IN FACT, THEY BOTH FELT THEY WERE UNDERMEDICATED." SHE AGAIN STATED THERE WERE "ABSOLUTELY NO ADVERSE EFFECTS" TO EITHER PT. ADDITIONAL EVENT INFO WAS REQUESTED, BUT THE CUSTOMER SOURCE DECLINED TO GIVE ANY FURTHER INFO, INCLUDING PT AND PROGRAM DETAILS, DUE TO THE FACT THAT "THERE WAS NO DEVICE MALFUNCTION TO REPORT." SHE STATES THEY HAVE RE-INSERVICED ALL NURSES AND HAVE EMPHASIZED THE CHANGE TO THE 5MG/ML CONCENTRATION VIALS. NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other