BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1844351 · Received September 24, 2010

    Report

    Report Number
    1423500-2010-03715
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    August 21, 2010
    Report Date
    September 1, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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). EVALUATION SUMMARY: THE DEVICE FAILED THE HOMECHOICE RETURN INSTRUMENT TEST/EVALUATION (RITE) FUNCTIONAL TEST DUE TO A RELOAD SET (RLS) 201 ALARM. THE DEVICE PASSED HOMECHOICE RITE ELECTRICAL TEST WITH NO ISSUES. THE RLS 201 ALARM DID NOT AFFECT VOLUMETRIC ACCURACY OR TEMPERATURE FUNCTIONAL PERFORMANCE AND THE DEVICE WAS DETERMINED TO MEET SPECIFICATIONS RELATIVE TO THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) FOUND IN THE LOGS ONLY. THE CAUSE OF THE IIPV WAS INSUFFICIENT DRAIN: ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. THE DEVICE HAS NOT BEEN PREVIOUSLY RETURNED FOR ANY ISSUES RELATED TO 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).

    Description of Event or Problem · 1

    AN INCREASED INTRAPERITONEAL VOLUME (IIPV) SITUATION WAS IDENTIFIED IN THE LOG OF A RETURNED HOMECHOICE (HC) DEVICE. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 3. THE PROGRAMMED FILL VOLUME WAS 1200ML. THE DRAIN VOLUME WAS 1928ML. THIS 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 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR