BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2832209 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05118
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)> THIS COMPLAINT FOR A LEAK WAS CONFIRMED DURING THE SAMPLE EVALUATION; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. A VISUAL INSPECTION WAS PERFORMED WITH A BROKEN OCCLUDER FOOT NOTED. LEAK TESTING WAS PERFORMED WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST WAS PERFORMED WITH NO ISSUES NOTED. A CLAMP FUNCTION TEST WAS PERFORMED WITH BROKEN OCCLUDER FEET NOTED. A VISUAL INSPECTION NOTED NO WHITISH SPOT ON THE OCCLUDER LEG THAT WOULD INDICATE POSSIBLE OVER-TORQUING.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER AN ISSUE OF LEAK ON TRANSFER SET FOUND DURING USE. THE CUSTOMER REPORTED THAT THE LIQUID WOULD NOT STOP EVEN AFTER CLOSING THE CLAMP ON THE TUBE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS,DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME H11K04049

    Patients

    Seq Age Sex Outcome Treatment
    1