BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1802503 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02494
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    July 10, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. THE PRODUCT ANALYSIS LAB (PAL) EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED IIPV FOUND IN THE DEVICE LOGS. THE DEVICE FUNCTIONED NORMALLY DURING PAL TESTING. REVIEW OF THE PREVIOUS SERVICE RECORD REVEALED NO ISSUES THAT COULD HAVE CAUSED THE REPORTED DIFFICULTY OF LOW DRAIN VOLUME ALARMS OR IIPV. THE CAUSE OF THE IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN, ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED. PRODUCT SURVEILLANCE CONTACTED THE NURSE AND PROVIDED THE NURSE WITH THE RESULTS OF EVALUATION. THE NURSE INDICATED THAT THE PATIENT IS CONTINUING WITH THERAPY. THE NURSE CONFIRMED THAT THERE WAS NO MEDICAL INTERVENTION OR PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED OCCURRENCE DATE (B)(6) 2010 DURING DRAIN CYCLE 5. THE DRAIN VOLUME WAS 3116 ML. THE PROGRAMMED FILL VOLUME WAS 1900ML. THIS DRAIN VOLUME MEETS OVERFILL CRITERIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1