BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1833914 · Received September 14, 2010

    Report

    Report Number
    1423500-2010-03397
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    July 4, 2010
    Report Date
    August 20, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AT BAXTER; HOWEVER, THE DEVICE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE INSUFFICIENT DRAIN AND USE ERROR: TIDAL ULTRAFILTRATION REMOVAL SET TOO LOW. A REVIEW OF THE DEVICE'S SERVICE HISTORY WAS PERFORMED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE. A LABELING REVIEW FOUND THE HOMECHOICE USER'S MANUAL TO BE ADEQUATE FOR THE USE/USER ERROR IDENTIFIED IN THIS INCIDENT. 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 OF A RETURNED HOMECHOICE DEVICE, AN INCREASED INTRAPERITONEAL VOLUME EVENT WAS IDENTIFIED WHICH OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 17. THE DRAIN VOLUME WAS 4281 MILLILITERS (ML). THE PROGRAMMED FILL VOLUME WAS 2400ML. THIS EVENT MEETS OVERFILL CRITERIA. PRODUCT SURVEILLANCE CONTACTED THE NURSE AND SHE CONFIRMED THAT THERE WAS NO INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THE HOMEPATIENT WAS DOING WELL ON THE NEW HOMECHOICE DEVICE.

    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 36 YR