BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASS.-4PRONG, EUR.

    MDR report key: 1250545 · Received November 14, 2008

    Report

    Report Number
    1423500-2008-00915
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: RESULTS INDICATE CONFIRMATION OF THE REPORTED EVENT OF AN ALARM DUE TO AN AIR LEAK IN THE CASSETTE. THE ROOT CAUSE WAS DETERMINED TO BE A CRACK AT THE END OF THE CASSETTE, OPPOSITE OF THE TUBING CONNECTIONS. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Description of Event or Problem · 1

    REPORTER REPORTED AN ALARM AFTER REMOVING AIR FROM THE SET AND INSERTING IT AGAIN. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASS.-4PRONG, EUR. 78FKX FKX BAXTER HEALTHCARE S08F30048

    Patients

    Seq Age Sex Outcome Treatment
    1