BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2251772 · Received September 16, 2011

    Report

    Report Number
    1423500-2011-12333
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    March 3, 2011
    Report Date
    April 3, 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).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THIS REPORT WAS CONFIRMED IN THE LAB FOR BROKEN OCCLUDER FEET ON ONE OF THE TWO SETS RETURNED, WHICH IS CONSISTENT WITH THE SYMPTOM DESCRIBED. THE CAUSE WAS UNDETERMINED. A BATCH REVIEW FOR THE QUOTED (SINGLE) MANUFACTURING LOT NUMBER SHOWED NO RELATED PROBLEMS. 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 USE FOR THREE WEEKS, TWO TRANSFER SETS WERE NOTED THAT THE LIQUID COULD NOT BE STOPPED EVEN IF CLOSING THE CLAMPS. THERE WAS NO USE OF ADDITIONAL DISINFECTANT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT. THIS IS REPORT 2 OF 2.

    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 H09I29050

    Patients

    Seq Age Sex Outcome Treatment
    1