BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 122704 · Received September 26, 1997

    Report

    Report Number
    2921482-1997-00179
    Event Type
    Death
    Date Received
    September 26, 1997
    Date of Event
    August 25, 1997
    Report Date
    August 28, 1997
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR FAILURE ANALYSIS. THE DEVICE HISTORY HAS BEEN REVIEWED WITH THE OBSERVATION THAT THE DEVICE WAS RELEASED AS A NEW DEVICE AND SUCCESSFULLY PASSED ALL TESTS AT THE TIME OF RELEASE. CUSTOMER RISK MANAGEMENT REPORTS THAT THEIR INVESTIGATION DID NOT INDICATE A DEVICE MALFUNCTION AND THEY WOULD NOT BE RETURNING THE PUMP FOR TESTING. THE FREQUENCY OF DEATH OR SERIOUS INJURY REPORTS FOR CODE 102 (OVERDELIVERY) FOR LIFECARE PCA PRODUCTS IS APPROXIMATELY 1.99/MILLION SETS.

    Description of Event or Problem · 1

    OVERDELIVERY REPORTED. THE PUMP WAS IN USE INFUSING MORPHINE 1MG/ML AT A CONTINUOUS RATE OF 8MG/HR. THE PUMP HAD BEEN IN USE FOR APPROX 5 DAYS WITHOUT INCIDENT PRIOR TO THE REPORTED EVENT. ON 8/25/1997, A NURSE REPORTS THAT SHE PLACED A NEW 30ML VIAL (#12) AT 9:15AM. AT 11:30AM THE DISPLAY INDICATED 15.4MG HAD INFUSED, HOWEVER, THE 30ML VIAL WAS EMPTY. ANOTHER VIAL (#13) WAS PLACED IN USE AT 11:45AM, AND AT 1:45PM THE DISPLAY INDICATED A DELIVERED AMOUNT OF 15.4MG. THE SECOND VIAL REPORTEDLY CONTAINED 5MG AT THAT TIME. THE PUMP WAS CHANGED OUT AND A THIRD VIAL WAS STARTED AT 2:00PM. THE PT, WHO HAD BEEN ADMITTED FOR END STAGE TERMINAL CANCER, EXPIRED AT 2:15PM. THE FIRST PUMP HAD BEEN TURNED OFF AND NO PROGRAMMING HISTORY WAS AVAILABLE. THE PT HAD BEEN ADMITTED FOR TERMINAL CARE BECAUSE THE PT FAMILY WAS NO LONGER ABLE TO CARE FOR HIM AT HOME. THE ATTENDING PHYSICIAN REPORTS THAT HIS DEATH WAS EXPECTED, AND THE PHYSICIAN FEELS THE PT DIED FROM HIS DISEASE PROCESS. NO FURTHER INFO WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death