BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2132960 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07792
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASSIGNABLE CAUSE FOR THE RETURN INSTRUMENT TEST/EVALUATION (RITE) FAILURE - VOLUMETRIC ACCURACY WAS DETERMINED TO BE DETERIORATED PISTON FOAM. THE PISTON FOAM WERE REPLACED WITH THE TEST ARTICLES. THE DEVICE THEN PASSED ACCURACY CONFIRMATION AND TEMPERATURE VERIFICATION TESTS. THERE WERE NO PROBLEMS FOUND DURING AN INTERNAL INSPECTION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED CONDITION. THE DEVICE WAS FORWARDED TO SERVICE FOR CORRECTIONS. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER DISCONTINUED USE OF THE HOMECHOICE (HC) BECAUSE THEY WERE TRANSFERRED TO HEMODIALYSIS. DURING TESTING BAXTER DETERMINED THAT THE DEVICE FAILED RITE (RETURNED INSTRUMENT TEST/EVALUATION) TESTING DUE TO: THERAPY MONITORED VOLUME FAILED PERFORMANCE SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 LOCAL (PD4) AMBUFLEX| LOCAL (PD4) ULTRABAG