BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1973476 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01281
    Event Type
    Malfunction
    Date Received
    January 31, 2011
    Date of Event
    December 25, 2010
    Report Date
    January 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    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 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV), WHICH WAS FOUND IN THE DEVICE LOG WAS NOT DUPLICATED DURING TESTING. THE ASSIGNABLE CAUSE WAS INSUFFICIENT DRAIN; USE ERROR, TIDAL ULTRAFILTRATION REMOVAL SET TOO LOW. A SERVICE HISTORY REVIEW WAS PERFORMED AND NO ISSUES WERE IDENTIFIED. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO BE SUFFICIENT. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). PER THE PERITONEAL DIALYSIS NURSE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    FIVE INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATIONS WERE IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THIS IS REPORT 2 OF 5. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 5. THE PROGRAMMED FILL VOLUME WAS 2400ML AND THE TOTAL DRAIN VOLUME WAS 4104 ML. THIS DRAIN VOLUME MEETS BAXTER?S IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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 67 YR