BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 222630 · Received May 7, 1999

    Report

    Report Number
    2921482-1999-00077
    Event Type
    Death
    Date Received
    May 7, 1999
    Date of Event
    April 7, 1999
    Report Date
    April 7, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FURTHER INFO OBTAINED ON 08/25/1999. DURING THE INITIAL INVESTIGATION, THE CUSTOMER CONTACT WOULD NOT SHARE ANY SPECIFIC DETAILS RELATED TO THE EVENT. AFTER THE AUTOPSY REPORT WAS RECEIVED BY USER FACILITY, THE CUSTOMER CONTACT DID DIVULGE DETAILS. ACCORDING TO THE CUSTOMER CONTACT, THE AUTOPSY DETERMINED CAUSE OF DEATH TO BE "PULMONARY CONGESTION DUE TO POLYPHARMACY." "AFTER THE PT EXPIRED, THE HOSPITAL STAFF DISCOVERED THAT HE HAD A BROUGHT A BAGFUL OF DRUGS WITH HIM INTO THE HOSPITAL." THE CUSTOMER CONTRACT DECLINED TO GO INTO ANY MORE SPECIFIC DETAIL. THE CUSTOMER CONTACT STATED THAT "THE PT HAD NOT RECEIVED ANY MORPHINE SINCE 2230 HOURS 04/06/1999" AND THE PT EXPIRED ON 04/07/1999 AT 0220 HOURS. THE CUSTOMER CONTACT WOULD NOT CONFIRM WHETHER THE MORPHINE HAD BEEN DISCONTINUED PER PHYSICIAN ORDER OR WHETHER THE PT WAS RECEIVING MORPHINE THROUGH A PCA BOLUS ONLY PROGRAM AND HAD NOT REQUESTED ANY PCA BOLUS DELIVERIES SINCE 2230 HOUR 04/06/99.

    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 UNKNOWN Death