BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1875183 · Received October 19, 2010

    Report

    Report Number
    1423500-2010-04630
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORT OF A LOOSE CAP WAS CONFIRMED BY VISUAL INSPECTION. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING ASSEMBLY ISSUE. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT (H10E02011) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. 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

    THE CUSTOMER REPORTED THE BLUE CAP WAS FOUND TO BE DETACHED PRIOR REMOVING THE CASSETTE FROM THE PACKAGING. NO PATIENT INJURY OR MEDICAL INTERVENTION IS ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10E02011

    Patients

    Seq Age Sex Outcome Treatment
    1