BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2182897 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09906
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 2, 2011
    Report Date
    July 4, 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 COULD NOT BE CONFIRMED IN THE LAB. THE REPORTED CONDITION WAS UNABLE TO DUPLICATE UNDER LAB CONDITIONS WITH THE RETURNED SAMPLE, THEREFORE, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE RETURNED SAMPLE DID NOT SHOW ANY VISUAL PROBLEM OR LEAKAGE. THE LOT NUMBER SHOWED NO PROBLEMS ON A BATCH REVIEW. IN THIS CASE THE EVALUATIONS DID NOT FIND ANY EVIDENCE OF ANY PROBLEM. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WILL BE PERFORMED FOR THE LOT NUMBER PROVIDED. THE PRODUCT SAMPLE HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED BY BAXTER FOR EVALUATION. SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER THAT LIQUID WAS COULD NOT BE STOPPED FROM THE TRANSFER SET EVEN IF CLOSING THE CLAMP. THERE WAS PATIENT INVOLVEMENT BUT NO PAITENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 H10J18075

    Patients

    Seq Age Sex Outcome Treatment
    1