BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2080497 · Received May 6, 2011

    Report

    Report Number
    1423500-2011-05611
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 13, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT WAS CONFIRMED. THE SET WAS RETURNED FOR COMPLAINT INVESTIGATION. THE SET WAS VISUALLY INSPECTED AND NOTED THAT THE PATIENT LINE WAS LOOSE FROM THE ORGANIZER. THE SET CONTAINED ALL CAPS, CLAMPS, NO OTHER MANUFACTURING ABNORMALITIES WAS NOTED. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT WITH NO ISSUES. PER THE RESULTS OF EVALUATION, THERE WAS NO EVIDENCE OF A CAUSE RELATED TO OPERATOR PACKING. THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. RENAL QUALITY ENGINEERING, ALONG WITH PLANT QUALITY AND MANUFACTURING PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED REPORT IN WHICH THE PATIENT LINE IS LOOSE. THERE IS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10K11094

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE