BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1960591 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00571
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 9, 2011
    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 DEVICE HAS BEEN RECEIVED BY BAXTER, AND THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED. REVIEW OF THE DEVICE LOGS REVEALED A DRAIN/ULTRAFILTRATION VOLUME MEETING PEDIATRIC INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA ON (B)(4) 2010 IN CYCLE 2 THE USER HAD AN ULTRAFILTRATION (UF) OF 117 ML (EST. DRAIN VOLUME 447 ML). THIS VOLUME WAS GREATER THAN 130% OF THE LARGEST PRESCRIBED FILL VOLUME OF 330 ML AND MET PEDIATRIC IIPV CRITERIA. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OR THE IIPV FOUND IN THE DEVICE LOGS. THE ASSIGNABLE CAUSE OF THE PEDIATRIC IIPV WAS DETERMINED TO BE: INSUFFICIENT DRAIN ONE OR MORE CYCLES ADVANCES TO NEXT FILL WHEN SLOW/ NO FLOW OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD. REVIEW OF THE SERVICE DATES AND ACTIVITIES REVEALED THE PREVIOUS RETURN OF THE DEVICE WAS NOT FOR THE REPORTED PROBLEM OF IIPV. THE DEVICE MET SPECIFICATIONS 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 DEVICE. THE IIPV OCCURRED ON (B)(6) 2010 DURING DRAIN CYCLE 2. THE PROGRAMMED FILL VOLUME WAS 330ML AND THE ULTRAFILTRATION (UF) WAS 117ML. THIS UF MEETS BAXTER'S IIPV CRITERIA. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 14 MO