BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1891898 · Received November 5, 2010

    Report

    Report Number
    1423500-2010-05364
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Date of Event
    May 17, 2010
    Report Date
    October 13, 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). THE CUSTOMER DISCONTINUED USE OF THE DEVICE FOR AUTOMATED PERITONEAL DIALYSIS THERAPY AND RETURNED IT TO THE (B)(4) FACILITY. THE DEVICE PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TESTS PERFORMED BY THE PAL. REVIEW OF THE RETURNED DEVICE LOGS REVEALED AN ADDITIONAL DIFFICULTY OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) HAD OCCURRED ON (B)(6) 2010 DURING CYCLE 1 WHEN THE DEVICE USER DRAINED OUT 4673ML, WHICH WAS 187% OF THE FILL VOLUME OF 2500 ML AND MET IIPV CRITERIA. THE DEVICE WAS FOUND TO MEET FUNCTIONAL SPECIFICATIONS RELATIVE TO THE IIPV IDENTIFIED VIA DEVICE LOG REVIEW. THE ASSIGNABLE CAUSE OF THE IIPV FOUND IN THE LOGS WAS DETERMINED TO BE: INSUFFICIENT DRAIN; FALSE EMPTY DETECT AND USE ERROR, INAPPROPRIATE BYPASS OF THE LOW DRAIN VOLUME ALARM. 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 MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF THE HOME CHOICE DEVICE AN INCREASED INTRAPERITONEAL VOLUME EVENT WAS FOUND IN THE EVENT LOGS THAT OCCURRED ON (B)(6) 2010 DURING CYCLE 1, DRAIN VOLUME 4673 ML. THIS EVENT MEETS OVERFILL CRITERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1