BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 3012497 · Received February 20, 2013

    Report

    Report Number
    1722139-2013-00088
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP FAILED VOLUMETRIC ACCURACY TEST. PUMP WAS RECALIBRATED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT PUMP DID NOT INFUSE WHAT IT WAS SET FOR. ATTEMPTS WERE MADE TO OBTAIN MORE DETAILS RELATED TO THE EVENT WITH NO RESPONSE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74632 CURLIN INFUSION IV PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 PAINSMART IOD

    Patients

    Seq Age Sex Outcome Treatment
    1