BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2260497 · Received September 22, 2011

    Report

    Report Number
    1423500-2011-12539
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Date of Event
    August 31, 2011
    Report Date
    September 5, 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 FOR DAMAGED MINI SET MAIN BODY. IN THIS CASE NO FUNCTIONAL PROBLEM WAS OBSERVED DURING THE PLANT EVALUATION, HOWEVER A VISUAL CRACK WAS CONFIRMED. ROOT CAUSE IS UNCERTAIN. THE LOT NUMBER IS UNKNOWN; THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS IS AN INTERNATIONAL REPORT OF A PATIENT THAT REPORTED A CRACK ON THE LIGHT BLUE MAIN BODY OF THE TRANSFER SET. IT HAD BEEN IN USE FOR ABOUT 80 DAYS. THERE WAS NO DISINFECTANT USE ON THE SET BY 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

    Patients

    Seq Age Sex Outcome Treatment
    1