BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURLIN INFUSION 4000PLUS IV PUMP

    MDR report key: 1981029 · Received February 1, 2011

    Report

    Report Number
    1722139-2011-00008
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 31, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: PERFORMANCE TESTS PERFORMED, ACCURACY AND ALARMS. THE PATIENT HISTORY LOG WAS REVIEWED TO VERIFY THERAPY PARAMETERS AND CHECK FOR SIGNS OF UNDER INFUSION. CONCLUSIONS: THE DEVICE PASSED THE +/-5% ACCURACY FLOW TESTS AND ALARM TESTS. THE HISTORY LOG SHOWS SUCCESSFUL INFUSIONS DURING 2010 WITH THE FOLLOWING PARAMETERS: 3.3 ML/HR RATE, 150ML DOSE, 46 HOUR DURATION. THE LAST INFUSION WAS RUN ON (B)(6) 2010 AND WAS SET TO RUN TO ABOVE PARAMETERS. THE THERAPY HAS 2 "UP OCCLUSION" ALARMS AND AFTER 18.2ML AND 18.5ML WERE DELIVERED. THE PUMP WAS THEN TURNED OFF. ON (B)(6) 2011, THE PUMP WAS SUCCESSFULLY RUN FOR 10 MINUTES AT 125 ML/HR AND 10ML DOSE. THE UNDER INFUSION COULD NOT BE DUPLICATED OR CONFIRMED. THE PATIENT IS OK AND RECEIVED THE REST OF THE INTENDED THERAPY WITH ANOTHER PUMP AT THE INFUSION CENTER. THE REASON FOR REPORTING THIS COMPLAINT IS BECAUSE THE PATIENT HAD A DELAY IN FINISHING THE THERAPY AND WENT TO THE INFUSION CENTER FOR ASSISTANCE.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: "FLOOR NURSE SAID PUMP DELIVERED LESS THAN THE 150ML IT WAS SET FOR." (B)(6) CLINICIAN CONTACTED IV MIXTURE TECHNICIAN AND HE REPORTED, "THE PATIENTS ARE SENT HOME WITH THE PUMP INFUSING CHEMOTHERAPY. THIS PUMP WAS ON A PATIENT INFUSING 5FU (FLUOROURACIL). HE STATES THAT THE PATIENT HAD TO RETURN TO THE INFUSION CENTER TO GET A NEW PUMP. IT DELAYED HIS THERAPY, BUT WITHOUT ANY INJURY; THE PATIENT IS "FINE." THE INFUSION WAS SUPPOSED TO BE 150ML AND ONLY INFUSED 18.5ML. THE INFUSION IS USUALLY 2 DAYS, BUT IS UNSURE AT WHAT POINT THE PATIENT NOTICED THE UNDER-INFUSION (WHETHER IT WAS AT THE VERY END OR DURING THE INFUSION PROCESS). THEY DID NOT KEEP THE ADMIN SET, BUT STATES IT WAS A FILTERED SET AND THE INFUSION WAS FROM A BAG. THEY DID NOT DO ANY TESTING ON THE PUMP AND ARE RETURNING IT TO (B)(6)."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention