BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1823117 · Received September 1, 2010

    Report

    Report Number
    1423500-2010-03087
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    May 20, 2010
    Report Date
    August 9, 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). DEVICE EVALUATION EXPECTED, BUT NOT YET COMPLETED. ANY RESULTS OF EVALUATION WILL BE PROVIDED IN A FOLLOW UP MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED AND PASSED THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND WAS FOUND TO MEET ELECTRICAL PERFORMANCE SPECIFICATIONS, BUT FAILED THE RITE FUNCTIONAL TEST DUE TO RELOAD THE SET (RLS) 151 ALARM. THE ASSIGNABLE CAUSE OF THE IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN - FALSE EMPTY DETECT AND USE ERROR, CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME % SETTING TOO LOW (80%). FOLLOW UP WITH THE PERITONEAL DIALYSIS (PD) NURSE REVEALED THAT THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS IN (B)(6) 2010. THE PD NURSE STATED THERE WAS NO RELATION TO THE HOME PATIENT'S PD THERAPY, HOMECHOICE DEVICE, OR ANY BAXTER SOLUTIONS. THE DEVICE WAS SUBSEQUENTLY FORWARDED TO SERVICE. 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 HOMECHOICE (HC) DEVICE, AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED WHICH OCCURRED ON DATE (B)(6) 2010 DURING DRAIN CYCLE 4. THE DRAIN VOLUME WAS 3384ML (MILLILITERS). THIS EVENT MEETS OVERFILL CRITERIA. ON (B)(6) 2010, (B)(4) CONTACTED THE NURSE AND THE NURSE REPORTED THAT THE PATIENT WAS TRANSFERRED TO HEMODIALYSIS. 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 FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR