BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 2914845 · Received December 7, 2012

    Report

    Report Number
    1722139-2012-01212
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 11, 2011
    Report Date
    December 3, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    Z-1870-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP HAD EXPERIENCED ERROR CODE 45 IN PUMP'S HISTORY. NEW PUMP SOFTWARE WAS INSTALLED. (B)(4).

    Description of Event or Problem · 1

    INFO RECEIVED INDICATES THE PUMP HAD EXPERIENCED ERROR CODE 45.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR MORPHINE SULFATE 1:1