BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN

    MDR report key: 1813143 · Received August 24, 2010

    Report

    Report Number
    1423500-2010-02831
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED TRANSFER SET WAS RECEIVED WITH A CAP ON THE DARK BLUE CONNECTOR AND NO CAP ON THE PATIENT CONNECTOR. THE TRANSFER SET WAS TESTED UNDERWATER AND A LEAK WAS NOTED. THE TRANSFER SET WAS VISUALLY INSPECTED AND IT WAS NOTED THAT BOTH OF THE OCCLUDER FEET WERE BROKEN. BASED ON THE INFORMATION OBTAINED FROM BAXTER'S INVESTIGATION, THE ROOT CAUSE OF THE BROKEN OCCLUDER FEET COULD NOT BE DETERMINED. A BATCH REVIEW WAS NOT PERFORMED SINCE THE LOT NUMBER WAS NOT AVAILABLE. RENAL QUALITY ENGINEERING AND THE MANUFACTURING SITE WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL FURTHER TAKE CORRECTIVE AND PREVENTIVE ACTION(S), AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE DRIVE CONNECTOR WAS NOT LINING UP PROPERLY. THE CASE WAS COMPLETED WITH ANOTHER DEVICE WITH NO ADVERSE PT CONSEQUENCES. THE CUSTOMER REPORTED THAT THE DEVICE WAS WORKING FINE AFTER THE PROCEDURE AND OPINES THAT THE EVENT WAS USER ERROR.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(6) THAT THE OCCLUDER FEET WERE BROKEN ON A TRANSFER SET USED FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE CUSTOMER REPORTED THAT THE TRANSFER SET HAD BEEN USED FOR 150 DAYS. THE CUSTOMER CONFIRMED THE PATIENT HAD BEEN OVER TORQUING THE TWIST CLAMP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1