BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3173495 · Received June 12, 2013

    Report

    Report Number
    1722139-2013-01893
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    January 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLATEN DOOR WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INVESTIGATION FOUND THAT IMPACT BENT PLATEN CAUSING PUMP COULD NOT CLOSE PROPERLY AND FAILED FREE FLOW TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267180 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 4000 CMS

    Patients

    Seq Age Sex Outcome Treatment
    1