BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2071095 · Received April 27, 2011

    Report

    Report Number
    1423500-2011-05091
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 17, 2011
    Report Date
    April 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED TRANSFER SET WAS RECEIVED WITH CAP ON DARK BLUE CONNECTOR AND NO CAP ON PATIENT CONNECTOR IN REFERENCE TO LEAK. A LAB TITANIUM ADAPTER WAS FUNCTIONALLY HAND TIGHTENED WITHOUT DIFFICULTY. THE TRANSFER SET WAS THEN TESTED UNDERWATER WITH LEAK NOTED. SET WAS VISUALLY INSPECTED AND NOTED THAT ONE OF THE OCCLUDER FEET WAS BROKEN. THE COMPLAINT WAS CONFIRMED IN THE LAB FOR A CRACK. A BATCH REVIEW WAS NOT PERFORMED AS LOT INFORMATION WAS NOT KNOWN. BASED ON THE INFORMATION GATHERED DURING BAXTER?S INVESTIGATION, THE ROOT CAUSE OF THIS REPORT WAS NOT DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER THAT LIQUID COULD NOT BE STOPPED (EVEN IF CLOSING THE CLAMP) WITH THE TRANSFER SET. THE TRANSFER SET WAS IN USE FOR A MONTH AND THERE WAS NO USE OF ADDITIONAL DISINFECTANT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 H10F28071

    Patients

    Seq Age Sex Outcome Treatment
    1