BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 2974566 · Received January 29, 2013

    Report

    Report Number
    1722139-2013-00117
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MOOG MED DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP SHOWED IMPACT BENT PLATEN CAUSING FREE FLOW AND PUMP FAILED 40 PSI TEST. PLATEN WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THAT PUMP CONSTANTLY FREE FLOWS WHEN THE SET ATTACHES DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39792 CURLIN INFUSION IV PUMP FRN MOOG MED DEVICES GROUP 4000 CMS

    Patients

    Seq Age Sex Outcome Treatment
    1