BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1082052 · Received July 23, 2008

    Report

    Report Number
    1423500-2008-00678
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    March 2, 2008
    Report Date
    June 26, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOMECHOICE MACHINE WAS REC'D AND EVALUATED. THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE PROBABLE CAUSE OF THIS OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN / MULTIPLE CYCLES, ADVANCED TO FILL WHEN LOW / NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD, AND/OR, INSUFFICIENT DRAIN. THE DEVICE WILL BE ROUTED TO THE SERVICE AREA.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE MACHINE, AN OVERFILL WAS DISCOVERED. IN THE THERAPY SESSION STARTED IN 2008, DRAIN 4, THE HOME PATIENT'S ULTRAFILTRATION (UF) READING WAS 790ML. THIS UF INDICATES THAT THE HOME PT DRAINED 790ML MORE THAN THE PROGRAMMED FILL VOLUME OF 2500ML FOR A TOTAL DRAIN OF 3290ML. THE HOME PT DID NOT EXPERIENCE ANY SYMPTOMS OF FULLNESS OR DISCOMFORT ASSOCIATED WITH THE INCIDENT. THE HOME PT'S NURSE CONFIRMED THERE WAS NO PT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH OVERFILL. NO ADDITIONAL INFO COULD BE OBTAINED REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR