BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 3158954 · Received June 3, 2013

    Report

    Report Number
    1722139-2013-01541
    Event Type
    Death
    Date Received
    June 3, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 3, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, PROVIDER HAD AN INCIDENT OCCURRED IN A PT'S HOME WHERE IT APPEARED THAT THE MOOG'S 4000 PUMP WAS REPROGRAMMED AND THE UNITS IN THE PCA MODE WAS CHANGED FROM MG TO ML. THIS RESULTED IN A 20-FOLD INCREASE IN THE HOURLY RATE AND BOLUS DOSE SINCE THE CONCENTRATION WAS PREVIOUSLY SET TO 20 MG/ML PRIOR TO THE PROGRAM CHANGE. THE PATIENT WAS HOSPITALIZED LOCALLY AND EXPIRED IN THE HOSPITAL APPROXIMATELY TWO DAYS LATER. ON (B)(6) 2013, (B)(4) MEDICAL CLINICAL NURSE REVIEWED THE PATIENT HISTORY AND IT SHOWED THAT THE BAG VOLUMES WERE CHANGED ON SEVERAL OCCASIONS TO VALUES WHICH HAPPEN TO REFLECT THE AMOUNT REMAINING IN THE BAG. ON ONE OCCASION A NEW PROGRAM WAS SET AND THE UNITS WERE CHANGED FROM MG TO ML AND THE BAG VOLUME WAS AGAIN CHANGED. ON (B)(6) 2013, (B)(4) MEDICAL CLINICAL NURSE HAD A CONVERSATION WITH THE CUSTOMERS AND SUGGESTED THE NURSING STAFF TO OBTAIN ADD'L TRAINING AND HAS REGULAR COMPETENCY TESTING BE PERFORMED. CUSTOMER ALSO HAD QUESTIONS REGARDING TO THE REPLACE SET 3 AND IF THERE WERE PUMPS ON THE MARKET THAT WOULD DEFAULT THE UNITS TO MG. SHE EXPLAINED THAT THE REPLACE SET 3 TYPICALLY INDICATED A NEED FOR A SET CHANGE, NO FURTHER ALARMS WERE DISCUSSED, AND INTRODUCED THAT (B)(4)'S 6000 PUMP DOES DEFAULT THE UNITS TO MG IN THE PCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243032 CURLIN INFUSION 4000CMS IV PUMP FRN MOOG MEDICAL DEVICES GROUP 4000CMS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death MORPHINE SULFATE