BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2063459 · Received April 19, 2011

    Report

    Report Number
    1423500-2011-04724
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS CONFIRMED FOR DAMAGED MINISET MAINBODY. THE ROOT CAUSE IS UNKNOWN. A BATCH REVIEW DID NOT CONFIRM THE ISSUE. BAXTER WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTATIVE ACTION AS APPROPRIATE. RENAL QUALITY ENGINEERING WILL CONTINUE TO TRACK AND TREND THESE COMPLAINT REPORTS AND TAKE CORRECTIVE AND PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT REGARDING A TRANSFER SET WITH SOME CRACKS ON THE TWIST SWITCH AFTER ONE MONTH OF USE. IT WAS REVEALED THAT NO DISINFECTANT WAS USED BY THE PATIENT OR DOCTOR. NO 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 H10F28071

    Patients

    Seq Age Sex Outcome Treatment
    1