BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2834228 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05295
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED DURING EVALUATION OF THE RETURNED SAMPLE; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. A VISUAL INSPECTION WAS PERFORMED WITH CRACKS ON THE LIGHT BLUE MAIN BODY NOTED. LEAK TESTING WAS PERFORMED WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST AND A CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF AN ISSUE OF A DAMAGED MINICAP TRANSFER SET, FOUND DURING USE. THE CUSTOMER STATED THAT THE "HANDLE" OF THE MINICAP TRANSFER SET WAS BROKEN DURING USE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY AND NO MEDICAL INTERVENTION RELATED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1