BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFECARE PCA 3

    MDR report key: 530641 · Received June 15, 2004

    Report

    Report Number
    2921482-2004-00352
    Event Type
    Injury
    Date Received
    June 15, 2004
    Date of Event
    May 6, 2004
    Report Date
    May 21, 2004
    Manufacturer
    HOSPIRA, INC.
    Product Code
    MEA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF AN ADVERSE EVENT WHILE THE DEVICE WAS IN CLINICAL USE. THE PUMP WAS PROGRAMMED TO DELIVER HYDROMOPHONE 1MG/ML IN THE PCA ONLY MODE, WITH A 0.5MG LOADING DOSE, A 0.3MG PCA DOSE, A 15 MINUTES PT LOCKOUT, AND A 1.2MG 1HR LIMIT. IT WAS REPORTED THAT THE PHYSICIAN ALSO ORDERED SUPPLEMENTARY DOSES OF HYDROMORPHONE 1-2MG FOR "BREAK-THROUGH PAIN" AND PHENERGAN 12.5-25MG FOR NAUSEA AND VOMITING. AT 1000, THE PT RECEIVED ONE UNIT OF FRESH FROZEN PLASMA. AT 1600, THE PT COMPLAINED OF NAUSEA AND WAS TREATED WITH AN UNSPECIFIED DOSE OF PHENERGAN. DURING A NURSING ASSESSMENT AT 1620, THE NURSE FOUND THE PT WAS "CYANOTIC AND APNEIC." A CODE WAS IMMEDIATELY CALLED. THE PT WAS INTUBATED AND TRANSFERRED TO THE ICU. FURTHER RESUSCITATION DETAILS WERE UNSPECIFIED. THE PUMP WAS REMOVED FROM CLINICAL SERVICE. WHILE IN THE ICU, A CHEST X-RAY WAS TAKEN IN ADDITION TO BLOOD WORK BEING DRAWN. IT WAS REPORTED THAT DUE TO THE PT'S "HYPOXIC EPISODE" CONFIRMED WITH BLOOD GAS RESULTS THAT INDICATED A HIGH CO2 LEVEL, AN EEG WAS ORDERED. THE EEG RESULTS INDICATED THE PT WAS "BRAIN DEAD". REPORTEDLY, "A FEW DAYS LATER, THE PT'S FAMILY DECIDED TO WITHDRAW LIFE SUPPORT." THE PT EXPIRED IN 2004 AT 1400. THE CUSTOMER ALSO STATED THAT "AT THIS TIME, THEY DON'T BELIEVE THE PCA PUMP HAD ANYTHING TO DO WITH THE PT'S DEATH." THE CUSTOMER CONTACT ALSO STATED THAT A "TRANSFUSION REACTION CANNOT BE RULED OUT." THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECARE PCA 3 PCA INFUSION PUMP MEA HOSPIRA, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R PHENERGAN, MFG BY WYETH-AHERST,| 1 UNIT OF FRESH FROZEN PLASMA, DISTRIBUTOR UNK.| HYDROMORPHONE, MFG BY ABBOTT LABS,