BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD PRIZM PUMP

    MDR report key: 503151 · Received November 26, 2003

    Report

    Report Number
    503151
    Event Type
    Death
    Date Received
    November 26, 2003
    Date of Event
    October 29, 2003
    Report Date
    November 19, 2003
    Manufacturer
    SIMS DELTEC, INC. (AKA SMITH MEDICAL)
    Product Code
    FRN
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT ON DILAUDID PCA AT 0.2 MG/HR WITH 0.2MG BOLUS Q 10 MINUTES PM. PT WAS STILL RATING THEIR PAIN HIGH. MD ORDERED AN INCREASE IN THE DOSE TO 0.5 MG/HR WITH 0.25 MG BOLUS Q 10 MINUTES PRN. PT'S PAIN BETTER LATER & WAS DOWN TO A ?. 3-4 HOURS LATER, PT FELL ASLEEP AND WAS SNORING LOUDLY. CAREGIVER CHECKED ON THEM LATER & PT WAS NOT BREATHING. PT TAKEN TO E.R. BUT COULD NOT BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD PRIZM PUMP AMBULATORY IV INFUSION PUMP FRN SIMS DELTEC, INC. (AKA SMITH MEDICAL) 6100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death IN 2003.| STRYKER PUMP FOR NERVE BLOCK PLACED DURING SURGERY