BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3191144 · Received June 14, 2013

    Report

    Report Number
    1722139-2013-01971
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FIRST TIME THE PUMP WAS SENT IN FOR SERVICE. THE PUMP'S MAINTENANCE DUE DATE WAS CHANGED FROM JULY 5, 2012 TO MAY 14, 2014. INVESTIGATION FOUND THAT PUMP FAILED VOLUMETRIC ACCURACY TESTS. PUMP WAS CALIBRATED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THAT PUMP DID NOT PASS FLOW ACCURACY TEST. IT WAS UNDER 8% WHEN TESTED AT RATE 125 ML/HR AND DOSAGE WAS 30 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272144 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 CMS IOD

    Patients

    Seq Age Sex Outcome Treatment
    1