BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLER DRAINAGE SET - MULTILINGUAL

    MDR report key: 1950092 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00173
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A LEAK IN THE DRAIN BAG WAS CONFIRMED IN THE LAB. THE SET WAS TESTED UNDERWATER WITH A LEAK NOTED FROM THE SEAL NEXT TO THE LARGE DRAIN PORT. THE BAG WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE FLAT SEAL DID NOT EXTEND INTO THE MAIN SEAL OF THE BAG. THE CAUSE OF THE LEAK WAS DETERMINED TO BE INSUFFICIENT BOND MANUFACTURING / QUALITY ISSUE. A BATCH REVIEW WAS PERFORMED AND NO ISSUES WERE NOTED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION. A 510 NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510 NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    A PATIENT REPORTED A LEAKING CYCLER DRAINAGE SET. THIS WAS NOTICED AFTER THERAPY WAS COMPLETED IN THE MORNING. THE PATIENT STATED THE DISCHARGE BAG WAS LEAKING, AND THAT THE SAMPLE WAS AVAILABLE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER DRAINAGE SET - MULTILINGUAL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ BAXTER HEALTHCARE - MOUNTAIN HOME H10G13048

    Patients

    Seq Age Sex Outcome Treatment
    1