BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD-PRIZM 6101 AMBULATORY INFUSION PUMP

    MDR report key: 477886 · Received August 12, 2003

    Report

    Report Number
    MW1029268
    Event Type
    Death
    Date Received
    August 12, 2003
    Date of Event
    July 22, 2003
    Report Date
    August 5, 2003
    Manufacturer
    DELTEC
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ORDER WAS RECEIVED FOR A PT CONTROLLED ANALGESIA (PCA) PUMP WITH DOSAGE OF FENTANYL. THE NURSE PROGRAMMED THE PUMP FOR 1MCG/1ML INSTEAD OF THE CORRECT CONCENTRATION OF 50MCG/1ML. THE NURSE THEN PROGRAMMED THE DEMAND DOSES IN 0.00MCG DOSES- THUS THE PT RECEIVED LESS THAN THE DOSAGE ORDERED (10MCG) BUT AT MUCH GREATER CONCENTRATION (50:1 - NOT 1:1 AS PROGRAMMED). IN THE MORNING, ANOTHER NURSE GAVE A 20MCG BOLUS OF FENTANYL TO THE PT. THE PCA PUMP DELIVERED 20ML (PROGRAMMED AS 1MCG/1ML) WHICH RESULTED IN THE BOLUS TO THE PT ACTUALLY IN THE AMOUNT OF 1,000MCG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CADD-PRIZM 6101 AMBULATORY INFUSION PUMP PCA PUMP FRN DELTEC CADD - PRIZM 6101 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Death