BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1961375 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00612
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED; THE REPORTED COULD NOT BE CONFIRMED OR DUPLICATED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY INSPECTED, AND NO PROBLEMS WERE FOUND WITH THIS DEVICE. 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). DEVICE EVALUATION EXPECTED, BUT THE DEVICE HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A PATIENT CONTACTED (B)(4) REGARDING ASSISTANCE WITH DRAINING 3290ML WHILE USING THE HOMECHOICE (HC) DURING THERAPY, IN THE INITIAL DRAIN CYCLE. (B)(4) REVIEWED PROGRAMMING, AND FOUND A FILL VOLUME OF 1900ML, A LAST FILL VOLUME OF 0ML. (B)(4) THEN REVIEWED THE THERAPY LOG AND FOUND A TIDAL DRAIN VOLUME OF 176ML, A TIDAL FILL VOLUME OF 2028ML, A TOTAL ULTRAFILTRATION VOLUME OF -1842ML, ZERO BYPASSES, AND ZERO MANUAL DRAINS. THIS MEET THE CRITERIA FOR INCREASED INTRAPERITONEAL VOLUME (IIPV). (B)(4) ADVISED THE PATIENT THEY WOULD ARRANGE A SWAP OF THE HC. THE PATIENT STATED THEY DO NOT DO MANUAL EXCHANGES DURING THE DAY. NO 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 - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1