BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT

    MDR report key: 1232095 · Received November 7, 2008

    Report

    Report Number
    1423500-2008-00895
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    June 2, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE UNAVAILABLE, PER THE NURSE.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL ON AN UNRELATED REPORT, THE HOME PATIENT'S NURSE REPORTED THE FOLLOWING: IN 2008, THE PATIENT NOTICED A LEAK BEFORE THERAPY AND DISCOVERED THAT THE TRANSFER SET (WHICH WAS PLACED ON THE PATIENT A WEEK EARLIER) HAD FALLEN OFF OF THE CATHETER. THE PATIENT REPORTED THIS TO THE CLINIC THE FOLLOWING DAY. THE PATIENT DID NOT KNOW HOW OR WHY THIS HAPPENED. THE NURSE STATED THEIR PATIENTS ARE TRAINED TO MAKE SURE THE CONNECTION IS TIGHT AND THIS TRANSFER SET WAS NOT LOOSE, IT JUST FELL OFF. A NEW TRANSFER SET WAS PLACED AND ONE GRAM OF VANCOMYCIN WAS GIVEN INTRAPERITONEAL (IP). AN EFFLUENT CULTURE WAS PERFORMED THAT DAY AND RESULTS WERE NEGATIVE. THE PATENT DID NOT HAVE ANY SIGNS OR SYMPTOMS OF PERITONITIS. THE SAMPLE WAS DISCARDED, PER THE NURSE. THE PATIENT IS CONTINUING WITH PERITONEAL DIALYSIS (PD) THERAPY AND IS DOING WELL WITH NO REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTD LIFE TRANS SET W/TWIST CLAMP-EX SHORT 78FKX FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1