BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3002799 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06049
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 18, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALAUTION SUMMARY:A VISUAL INSPECTION WAS PERFORMED AND CONFIRMED THE CONDITION. THE UNIT HAD BROKEN OCCLUDE FEET. LEAK TESTING PERFORMED, WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST WAS PERFORMED, WITH NO ISSUES NOTED. CLAMP FUNCTION TEST WAS PERFORMED, FINDING BROKEN OCCLUDE FEET. IT WAS NOTED THAT THERE WERE WHITISH SPOTS ON THE OCCLUDER LEG THAT WOULD INDICATE OVER-TORQUING. HOWEVER, THE CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF EVALUATION, OR SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN OPENING A MINICAP TRANSFER SET FOR THERAPY, THE TRANSFER SET OVER TWISTED AND CAME OFF INSTEAD OF LOCKING IN; THERE WAS NO LEAK REPORTED IN THIS EVENT. THERE WAS PATIENT INVOLVEMENT BUT NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105584 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1