BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1064171 · Received June 18, 2008

    Report

    Report Number
    1423500-2008-00499
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 24, 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

    ADD'L PMA/510(K) #: K012988.

    Description of Event or Problem · 1

    DURING A CALL FOR TECHNICAL ASSISTANCE, A HOME PT REPORTED A POTENTIAL OVERFILL SITUATION. THE HOME PT CONTACTED A BAXTER TECHNICAL SVC REP (TSR) REGARDING A LOW DRAIN VOLUME ALARM THAT APPEARED ON THE DISPLAY OF THE HOMECHOICE DEVICE DURING THE INITIAL DRAIN. THE DRAIN VOLUME WAS 34 ML; THE LAST VOLUME INFUSED WAS 2000 ML. THE TSR ASSISTED THE HOME PT WITH TROUBLESHOOTING. THE HOME PT STATED THAT THERE MAY BE A SMALL BIT OF FIBRIN STUCK IN THE CATHETER. THE TSR ASSISTED THE HOME PT WITH BYPASSING TO FILL 1 TO FLUSH THE LINES THEN THE HOME PT DRAINED 4041 ML. THE HP ADVISED THAT SHE HAS BEEN RETAINING FLUID. THE TSR PLACED THE HOME PT BACK IN FILL 1 TO RESUME THE THERAPY AND WAS FLOWING OKAY AFTER THE FLUSH. PER THE HOME PT'S NURSE, THE PT WAS NOT EXPERIENCING ANY SYMPTOMS OF OVERFILL AT THE TIME OF THE REPORT, BUT NO FURTHER INFORMATION COULD BE OBTAINED.

    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