BEUDAMED
    FDA Adverse Event Other Summary report: N

    CURLIN INFUSION 2000PLUS IV PUMP

    MDR report key: 1749366 · Received June 28, 2010

    Report

    Report Number
    1722139-2010-00072
    Event Type
    Other
    Date Received
    June 28, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ON DAY 30 AFTER THE COMPLAINT WAS RECEIVED, THE PUMP HAD NOT BEEN RETURNED. AFTER MOOG CLINICAL STAFF CONTACTED THE CUSTOMER AGAIN ON 06/25/2010, THE CUSTOMER SAID THE PUMP IS CURRENTLY IN USE, BUT ONCE IT IS DONE, THEY WILL RETURN IT TO MOOG. IT APPEARS THEY BELIEVE THERE WAS SOME KIND OF USER ERROR AS THEY'VE CONTINUED USING THE DEVICE DURING THE LAST 30 DAYS AND THAT THEY WOULDN'T HAVE SENT THE DEVICE BACK TO MOOG IF WE HAD NOT CONTACTED THEM AGAIN TODAY/ UPON RECEIPT OF THE DEVICE, MOOG WILL CONDUCT AN EVALUATION AND ATTEMPT TO DUPLICATE THE EVENT.

    Description of Event or Problem · 1

    REPORTED BY THE CUSTOMER AS: PT ORDERED 60ML BAG OF HYDROMORPHONE (CONCENTRATION 2MG/ML) TO BE DELIVERED AT A RATE OF 4MG/HR WITH A .5ML BOLUS EVERY 15 MINUTES AS NECESSARY AT A BASAL RATE OF 1 MG/HR. ELEVEN HOURS INTO THE TREATMENT THE PUMP INDICATED THE INFUSION WAS COMPLETED, BUT STILL HAD 30ML LEFT IN THE BAG (505% OF THE DOSE ORDERED). AT THAT TIME THE PT HAD SEVERE RESPIRATORY DEPRESSION AND THE NURSE CALLED THE PHARMACIST AT FOX INFUSION WHO DELIVERED 2 DOSES OF NARCAN AND THE PT RECOVERED. SIX BOLUSES WERE DELIVERED DURING THIS TIME. AT THIS TIME THE PUMP IS ON ANOTHER PT AND WHEN IT RETURNS, IT WILL BE SENT IN TO MOOG FOR REVIEW. PT INJURY- YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION 2000PLUS IV PUMP FRN MOOG MEDICAL DEVICES GROUP

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention