BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2091930 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06108
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 26, 2011
    Report Date
    May 4, 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). THIS COMPLAINT WAS CONFIRMED IN THE LAB FOR BROKEN OCCLUDER FEET. BROKEN OCCLUDER MECHANISMS PREVENT PROPER CLAMPING OF THE TUBING AND GENERALLY RESULT IN AN INTERNAL TUBING LEAK OR LACK OF FLUID SHUT-OFF THROUGH THE SET. THE ROOT CAUSE IS UNDETERMINED. A BATCH REVIEW FOR THE MANUFACTURING LOT SHOWED NO RELATED PROBLEMS DURING PRODUCTION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. IF THE SAMPLE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT THE DARK BLUE CONNECTOR CANNOT CONNECT THE TUBING TIGHTLY. THE LIQUID LEAKED FROM THE JOINT FACE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT.

    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 H10J11054

    Patients

    Seq Age Sex Outcome Treatment
    1