BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN INFUSION IV PUMP

    MDR report key: 2830471 · Received October 10, 2012

    Report

    Report Number
    1722139-2012-01016
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FOUND THAT PUMP'S PREVENTATIVE MAINTENANCE DATE WAS PAST DUE ON (B)(4) 2011. AN IMPACT ALSO CAUSES PLATEN TO BENT ASIDE AND DOOR SWITCH'S SCREW CAME LOOSE. THESE CAUSES PUMP TO ALARM DOOR OPEN WHEN IN OPERATION AND FAIL VOLUMETRIC ACCURACY TESTS. PLATEN WAS REPLACED AND DOOR SWITCH'S SCREW WAS TIGHTEN TO RESOLVE THE ISSUES.

    Description of Event or Problem · 1

    INFORMATION RECEIVED INDICATES THAT PUMP STATES INFUSED, BUT ZERO IS DELIVERED DURING TESTING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1