BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN 4000CMS

    MDR report key: 1591619 · Received January 19, 2010

    Report

    Report Number
    1591619
    Event Type
    Death
    Date Received
    January 19, 2010
    Date of Event
    January 6, 2010
    Report Date
    January 18, 2010
    Manufacturer
    MOOG MEDICAL DEVICE GROUP
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RN NOTED 100 ML BAG INFUSING AT 1933 AT 0.5 MG/HR = 0.1 ML/HR. RECEIVED CALL FROM FAMILY AT 2130 THAT 100 ML BAG WAS EMPTY. UPON ASSESSMENT BY RN 2215, BAG WAS EMPTY, PUMP SETTINGS INDICATE CORRECT SETTINGS, NO EVIDENCE OF LEAKAGE OR FLUID ANY AROUND PT. CORONER REPORT SHOWS PT HAD 100 ML = 500 MG DILAUDID IN HER BLOOD STREAM. PUMP EVENT LOG SHOWS 0.0 ML INFUSED EVEN UPON PRIMING, BOLUS AND INFUSION. PUMP RETURNED TO DISTRIBUTOR THEN TO MFR FOR FURTHER EVALUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN 4000CMS CURLIN PUMP FRN MOOG MEDICAL DEVICE GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death