BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1863867 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04265
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    June 24, 2010
    Report Date
    September 16, 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). REVIEW OF THE DEVICE LOGS REVEALED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) THAT HAD OCCURRED ON (B)(6) 2010 DURING CYCLE 5 WHEN THE USER DRAINED 2467 ML, WHICH WAS GREATER THAN THE LARGEST PRESCRIBED FILL VOLUME OF 1500 ML AND MET IIPV CRITERIA. EXTERNAL VISUAL INSPECTION REVEALED THE HEATER PAN PAINT WAS FOUND TO BE CHIPPED, AND AN INTERNAL VISUAL INSPECTION REVEALED NO PROBLEMS. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE IIPV FOUND IN THE DEVICE LOGS. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE IIPV FOUND IN THE DEVICE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN DUE TO ONE OR MORE CYCLES ADVANCING TO THE NEXT FILL WHEN SLOW / NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. A SERVICE HISTORY REVIEW REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUE OF 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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) WAS IDENTIFIED ON (B)(6) 2010 DURING CYCLE 5. THE PATIENT'S LARGEST PRESCRIBED FILL VOLUME (LPFV) WAS 1500 ML AND THE DRAIN VOLUME WAS 2467 ML, WHICH MET IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 1

    PRODUCT SURVEILLANCE NOTIFIED THE HOME PATIENT (HP)'S NURSE OF THE INCIDENT OF IIPV THAT WAS FOUND DURING THE DEVICE EVALUATION.

    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