BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1900736 · Received November 16, 2010

    Report

    Report Number
    1423500-2010-05822
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    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 THE REPORT OF DISCOLORED. DURING VISUAL INSPECTION, IT WAS NOTED THAT THE TRANSFER SET CONTAINED RESIDUE INSIDE THE SILICONE TUBING. A LAB TITANIUM ADAPTER WAS FUNCTIONALLY HAND TIGHTENED WITHOUT DIFFICULTY AND PRESSURE TESTED UNDERWATER WITH NO LEAK NOTED. DURING VISUAL INSPECTION, THE TUBING WAS CUT TO VERIFY RESIDUE INSIDE THE TUBING. THE RESIDUE APPEARED A CRYSTALLIZED SUBSTANCE. THIS REPORT WAS CONFIRMED IN THE LAB. THE RESULTS OF A BATCH REVIEW REVEALED NO PROBLEMS DURING THE MANUFACTURING PROCESS AND NO DEVIATIONS FROM STANDARD PROCEDURE. BASED ON THE INFORMATION OBTAINED FROM 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). 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. A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. EVALUATION OF THE DEVICE HAS BEGUN; HOWEVER, HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE EVALUATION A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT THE HOSPITAL STAFF NOTICED A CRYSTALLINE FALL OUT OF A USED TRANSFER SET OF ONE RENAL PERITONEAL DIALYSIS (PD) PATIENT. THE INCIDENT WAS NOTED DURING A DRAIN CYCLE; THE CRYSTALLINE WAS SEEN IN THE TUBING GOING AWAY FROM THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H08K17038

    Patients

    Seq Age Sex Outcome Treatment
    1