BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1904515 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-06081
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 17, 2010
    Report Date
    October 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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 OPERATIONAL AND IN GOOD CONDITION. WITH REFERENCE TO THE IIPV DECISION TREE, THE CAUSE FOR THE IIPV FOUND IN THE DEVICE LOGS WAS DETERMINED TO BE INSUFFICIENT DRAIN - FALSE EMPTY DETECT AND USE ERROR; THE CLINICIAN INAPPROPRIATELY SET MINIMUM DRAIN VOLUME % SETTING TOO LOW. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE IIPV. THE DEVICE HAS NOT BEEN PREVIOUSLY SERVICED BY BAXTER. 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 5. THE PROGRAMMED FILL VOLUME WAS 1700ML AND THE TOTAL DRAIN VOLUME WAS 2731ML. THIS DRAIN 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 HOMECHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR