BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRYKER PAINPUMP

    MDR report key: 415187 · Received August 7, 2002

    Report

    Report Number
    1811755-2002-00033
    Event Type
    Death
    Date Received
    August 7, 2002
    Date of Event
    July 25, 2002
    Report Date
    August 7, 2002
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    MEB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT IS ALLEGED BY THE FAMILY OF THE DECEASED THAT A PAINPUMP INFUSED 90 CCS OF 0.5% MARCAINE WITH EPINEPHRINE IN "ONE DAY" FOLLOWING A SHOULDER ARTHROSCOPY PROCEDURE. IT WAS REPORTED BY THE HOSPITAL RISK MANAGER THAT "THE PATIENT HAD COMPLAINED OF DIZZINESS AND LOST CONSCIOUSNESS AT HOME." THE HOSPITAL RISK MANAGER REPORTED THE PATIENT WAS BROUGHT TO THE E.R. BY THE EMERGENCY MEDICAL SYSTEM STAFF AT 1400 IN 2002 WITH NO SIGNS OF LIFE AND WAS PRONOUNCED DEAD. IT WAS ALSO REPORTED BY THE FAMILY THAT "THE PATIENT HAD EXPERIENCED SEVERE CHEST PAINS FOR A FEW DAYS." THE PATIENT DIED APPROXIMATELY THREE DAYS AFTER THE PUMP WAS PLACED. ACCORDING TO THE PHYSICIAN WHO PLACED THE PUMP, "THE PUMP HAD NO RELATIONSHIP TO THE CAUSE OF THE PATIENT'S DEATH WHETHER IT INFUSED IN ONE DAY OR THREE." THE PHYSICIAN ALSO STATED THAT THE PATIENT WAS "NOT IN GOOD HEALTH." THE HOSPITAL RISK MANAGER REPORTED, THE PRELIMINARY CAUSE OF DEATH TO BE A PULMONARY EMBOLISM. A REQUEST FOR A TOXICOLOGY REPORT WAS SENT . THE CORONER WILL NOTIFY STRYKER INSTRUMENTS WHEN THE TOXICOLOGY REPORT IS AVAILABLE AND WILL NOT RELEASE THE DEVICE UNTIL THE REPORT IS FINALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER PAINPUMP INFUSION, PUMP MEB STRYKER INSTRUMENTS 0500-120-000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death