BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1894317 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05527
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    October 3, 2010
    Report Date
    October 15, 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). ON (B)(6) 2011, BAXTER PRODUCT SURVEILLANCE CONTACTED THE NURSE TO PROVIDE INFORMATION REGARDING THE OVERFILL. THE NURSE STATED THAT THE HOMEPATIENT IS DOING WELL ON THE NEW CYCLER AND STATED THAT SHE WOULD VERIFY THE SETTINGS WITH THE PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED OPERATIONAL AND IN GOOD CONDITION. THE DEVICE PASSED THE HOMECHOICE RITE (RETURN INSTRUMENT TEST / EVALUATION), FUNCTIONAL AND ELECTRICAL TESTS AND WAS FUNCTIONING WITHIN SPECIFICATION. A REVIEW OF THE DEVICE LOGS REVEALED A DRAIN VOLUME THAT MEETS THE IIPV (INCREASED INTRA-PERITONEAL VOLUME) CRITERIA. THE CAUSE FOR THE IIPV FOUND IN THE DEVICE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN, USE ERROR: TIDAL UF REMOVAL SET TOO LOW. THE CURRENT LABELING FOR THE HOMECHOICE/HOMECHOICE PRO APD SYSTEMS TRAINER'S GUIDE, WAS FOUND TO BE SUFFICIENT. 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 CAPA INVESTIGATION (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION EXPECTED BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP EMDR.

    Description of Event or Problem · 1

    DURING INITIAL ASSESSMENT OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WHICH OCCURRED ON (B)(6) 2010, DURING DRAIN CYCLE 4. THE DRAIN VOLUME WAS 2632 MILLILITERS (ML). THIS EVENT 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 52 YR