BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1974326 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01312
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    July 13, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. DURING VISUAL INSPECTION, CHIPPING / FLAKING OF THE LIGHT BLUE MAIN BODY WAS NOTED. THE REPORTED CONDITION WAS CONFIRMED IN THE LAB FOR CRACK. THE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING MANUFACTURE OF THE LOT. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    BAXTER (B)(4) REPORTED THAT AFTER 10 DAYS OF USE, IT WAS OBSERVED THAT LIQUID COULD NOT BE STOPPED EVEN WHEN CLOSING THE CLAMP OF THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO FURTHER INFORMATION IS AVAILABLE.

    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 H09H19087

    Patients

    Seq Age Sex Outcome Treatment
    1