BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2093476 · Received May 18, 2011

    Report

    Report Number
    1423500-2011-06103
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 30, 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). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS NOT CONFIRMED AS NO SAMPLE WAS RETURNED. THE ROOT CAUSE IS UNKNOWN. A BATCH REVIEW FOR THE LOT NUMBER SHOWED NO SIMILAR PROBLEMS NOTED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT SOME CRACKS ON THE LIGHT BLUE MAIN BODY OF THE TRANSFER SET WERE SEEN AFTER TEN DAYS OF USE. THERE WAS NO DISINFECTANT USED ON THE SET BY THE PATIENT OR DOCTOR. 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 H10H30032

    Patients

    Seq Age Sex Outcome Treatment
    1