BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION 6000 PUMP

    MDR report key: 3062608 · Received March 18, 2013

    Report

    Report Number
    1722139-2013-00168
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    January 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT THE FLUID INGRESS INTO PUMP CAUSING PCB TO CORRODE AND BATTERIES IN USE TO GET HOT TO THE TOUCH WHEN TURNED ON. PCB WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT BATTERIES IN USE WITH PUMP GET HOT TO THE TOUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111640 CURLIN INFUSION 6000 PUMP FRN MOOG MEDICAL DEVICES GROUP 6000 CMS IOD

    Patients

    Seq Age Sex Outcome Treatment
    1