BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFECARE PCA PLUS INFUSER

    MDR report key: 365991 · Received December 11, 2001

    Report

    Report Number
    2921482-2001-00489
    Event Type
    Death
    Date Received
    December 11, 2001
    Date of Event
    November 5, 2001
    Report Date
    November 14, 2001
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MANDATORY MEDWATCH FORM RECEIVED FROM THE USER FACILITY OF A PT DEATH WHILE THE DEVICE WAS IN USE. THE REPORT STATES: "PRELIMINARY FINDINGS: PT TO OR - PCA PROGRAMMED IN RECOVERY ROOM. ADMINISTERING DILAUDID. APPEARS PT RECEIVED INCORRECT AMOUNT OF MEDICATION. PT EXPERIENCED CARDIAC/RESPIRATORY ARREST." THE CUSTOMER WAS CONTACTED AND ADD'L INFO WAS RECEIVED. THE PT WAS BROUGHT TO THE RECOVERY ROOM AFTER SURGERY AND RECEIVED 0.2MG OF DILAUDID IV PUSH FOR PAIN AT 11:20AM, 11:30AM, 11:40AM, 11:51AM, 12:00PM, 12:05PM, 12:15PM, 12:25PM AND 12"30PM. AFTER THE LAST DOSE, THE PT REPORTED THAT PAIN LEVEL WAS "11" ON A SCALE OF 1-10 (10 BEING THE MOST PAIN). AT THIS TIME, THE PHYSICIAN ORDERED THE PT TO BE STARTED ON PCA DILAUDID. THE PUMP WAS PROGRAMMED WITH 1 MG/ML CONCENTRATION TO DELIVER A 0.2MG PCA DOSE WITH AN 8-MINUTE PT LOCKOUT AND A 5MG 4-HOUR LIMIT. NO LEADING DOSE WAS ORDERED FOR THE PT, BUT THE CUSTOMER CONTACT MENTIONED A LOADING DOSE OF 10MG BEING ON THE PRINTED PUMP HISTORY. THOUGH REQUESTED, THE TIME OF THIS LOADING DOSE WAS NOT REPORTED. THE PCA WAS INITIATED AT 1:00PM. AT 1:30PM, THE PT'S PAIN LEVEL WAS REPORTED TO BE AT A "4". THE PT WAS TRANSFERRED TO A REGULAR FLOOR AT 2:15PM. THE PT WAS REPORTED TO BE ALERT AND ORIENTED BETWEEN 2:30 AND 4:30PM, AS THE PT HAD FAMILY MEMBERS AND MDS IN THE ROOM. ACCORDING TO THE CUSTOMER CONTACT, THE PT WAS FOUND AT 4:40PM IN FULL CARDIOPULMONARY ARREST. IN THE COURSE OF THE RESUSCITATION EFFORTS, THE PCA WAS STOPPED AND THE PT WAS REPORTED TO EXPERIENCE SEIZURES. THE PT WAS RESUSCITATED AND PLACED ON LIFE-SUPPORT. THE 30ML VIAL OF MEDICATION THAT WAS REMOVED FROM THE PUMP HAD 12ML REMAINING. THE VOLUME EXPECTED TO REMAINING WAS NOT KNOWN. APPROX 48 HRS AFTER THE ARREST, THE PT WAS NOTED TO HAVE MINIMAL BRAIN ACTIVITY PER AN EEG, WAS REMOVED FROM LIFE-SUPPORT AND EXPIRED. ACCORDING TO THE CUSTOMER CONTACT, THE LOCAL CORONER WAS CONTACTED AND DETERMINED THAT THE PT DEATH WAS NOT A CORONER'S CASE. THE FACILITY WAS TO PERFORM AN AUTOPSY ON THE PT, INCLUDING TOXICOLOGY, BUT THE RESULTS ARE UNKNOWN AT THIS TIME. IT WAS REPORTED THAT THE "PCA PUMP DOES NOT LOOK LIKE IT WAS A FACTOR" IN THE PT'S DEATH.

    Description of Event or Problem · 1

    CO HAS KEPT IN REGULAR CONTACT WITH THE REPORTING FACILITY SINCE THE EARLIEST REPORT AND HAVE CONTINUED THOSE CONTACTS THROUGH 1/22/2002. HOWEVER, DESPITE SEVERAL ATTEMPTS CO HAS NEVER BEEN MADE AWARE OF THE AUTOPSY RESULTS. ALL PT AND EVENT CODES WERE PROVIDED TO CO BY THE REPORTING FACILITY. CO REPORTED "DEVICE NOT RETURNED - NO EVAL WILL BE PERFORMED." WHILE THE FACILITY HAS SEQUESTERED THE PUMP, CO HAS BEEN TOLD THAT THE DEVICE WAS TESTED AND FUNCTIONED WITHOUT ANY PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55810 LIFECARE PCA PLUS INFUSER INFUSION PUMP MEA ABBOTT LABORATORIES NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death