BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 92241 · Received May 16, 1997

    Report

    Report Number
    2921482-1997-00075
    Event Type
    Death
    Date Received
    May 16, 1997
    Date of Event
    April 11, 1997
    Report Date
    April 15, 1997
    Manufacturer
    ABBOTT LABORATORIES, ABBOTT NEW ZEALAND
    Product Code
    MEA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPT RECEIVED FROM ABBOTT INTL AFFILIATE INDICATING OVERDELIVERY. THE RPT STATES: "PUMP NOT RECORDING ACCURATELY. PCA LOCKOUT NOT WORKING. PT BECAME VERY SEDATED AND DROWSY." THE PUMP HAD BEEN SET TO INFUSE MORPHINE 1 MG/ML, PCA DOSE OF 2 MG WITH A 6 MINUTE PT LOCKOUT INTERVAL AND A 15 MG 4 HOUR DOSE LIMIT. THE PUMP WAS DISCONTINUED AND THE DRUG EFFECTS ALLOWED TO WEAR OFF. NO OTHER MEDICAL INTERVENTION WAS REQUIRED, NO ADVERSE SEQUELAE WERE RPTD. PCA THERAPY WAS THEN RE-INSTATED WITH A DIFFERENT PUMP. WHEN REVIEWED, THE NURSING "PCA/INFUSION OBSERVATION SHEET" RECEIVED WITH THE REPORT DOES NOT HAVE THE TOTAL DELIVERED AMOUNT ADDED UP CORRECTLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other