BEUDAMED
    FDA Adverse Event Death Summary report: N

    BARD PCA SYSTEM

    MDR report key: 302064 · Received October 27, 2000

    Report

    Report Number
    MW1020252
    Event Type
    Death
    Date Received
    October 27, 2000
    Date of Event
    March 26, 1998
    Report Date
    October 27, 2000
    Manufacturer
    CR BARD, INC.
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/27/01: THE FORM WAS SUBMITTED FOR A BARD PCA PUMP PROBLEM. THIS PRODUCT WAS MFG BY BARD MEDSYSTEMS DIV. THIS DIV WAS SOLD TO BAXTER HEALTHCARE CORP ON 2/26/96.

    Description of Event or Problem · 1

    PT WAS ADMITTED FOR REMOVAL OF BENIGN CYST. THE SURGERY HAD NO COMPLICATIONS. PT WAS GIVEN 10MG MORPHINE, VIA PCA, 15 MG OF DEMEROL IV, 35 MG DEMEROL AND 18.75 MG PHENERGAN IM BETWEEN 9145 - 11 AM. PT WAS THEN MOVED TO MED-SURG FLOOR. ALTHOUGH IT IS DISPUTED, THE FAMILY SAYS THE NURSE INSTRUCTED THE PT'S FAMILY MEMBER TO PUSH THE PCA BUTTON EVERY FIVE MINS. THE PT RECEIVED MORPHINE THROUGHOUT THE DAY, ABOUT 60 MG BY 3:30 PM. THE PT CONTINUED TO REMAIN IN A DEEP SLEEP AND COULD NOT BE AROUSED. PT ARRESTED AT 6:25 PM. THE CORONER'S REPORT STATED THE CAUSE OF DEATH WAS HYPOXIC ENCEPHALOPATHY FOLLOWING RESUSCITATION FOR CARLOPULMONARY ARREST DUE TO MORPHINE INTOXICATION FOR POST OPERATIVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PCA SYSTEM PCA PUMP MEA CR BARD, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death