BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2080460 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05608
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED TRANSFER SET WAS RECEIVED WITH NO 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. THE SET WAS VISUALLY INSPECTED; IT WAS NOTED THAT BOTH OF THE OCCLUDER FEET WERE BROKEN AND THERE WAS CHIPPING/FLAKING AND CRACK OF THE LIGHT BLUE MAIN BODY. DURING VISUAL INSPECTION, IT WAS FURTHER NOTED THAT THERE WAS NO WHITISH SPOT ON THE OCCLUDER LEG THAT INDICATES POSSIBLE OVERTORQUING. THE REPORTED CONDITION WAS CONFIRMED IN THE LAB FOR LEAK. A BATCH REVIEW FOR THE MANUFACTURING LOT NUMBER SHOWED NO RELATED PROBLEMS. BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE LEAK WAS NOT DETERMINED. BAXTER HAS CONDUCTED A TREND VIEW AND SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. 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 FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER THAT A TRANSFER SET LEAKED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    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 H10G28038

    Patients

    Seq Age Sex Outcome Treatment
    1