BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1863979 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04293
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    July 22, 2010
    Report Date
    September 17, 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). EVALUATION SUMMARY: THE DEVICE PASSED THE RETURN INSTRUMENT TEST/EVALUATION ELECTRICAL SAFETY ANALYZER TEST BUT FAILED THE RITE FUNCTIONAL TEST FOR A RELOAD SET 152. THE DEVICE WAS MADE OPERATIONAL BY REPLACING THE CUT TUBING ON THE VSR PRESSURE TRANSDUCER TUBING. THE DEVICE PASSED TEMPERATURE VERIFICATION AND ACCURACY TESTING. THE CAUSE OF THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) IDENTIFIED IN THE DEVICE LOGS WAS: INSUFFICIENT DRAIN USE ERROR-TIDAL ULTRAFILTRATION REMOVAL SET TOO LOW. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. REVIEW OF THE SERVICE DATES AND ACTIVITIES REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR THE REPORTED PROBLEM OF IIPV WITH NO ISSUES IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUES OF IIPV. 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    FOUR INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATIONS WERE IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THIS IS REPORT 2 OF 4. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 7. THE ULTRAFILTRATION WAS 1477ML. THIS DRAIN VOLUME MEETS BAXTER'S IIPV 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 41 YR