BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1046865 · Received May 14, 2008

    Report

    Report Number
    1423500-2008-00363
    Event Type
    Malfunction
    Date Received
    May 14, 2008
    Date of Event
    September 17, 2007
    Report Date
    April 21, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADD'L 510(K)- K923065. EVAL SUMMARY: THE EVAL DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE OVERFILL IDENTIFIED DURING THE EVAL. BASED ON A REVIEW OF ALL AVAILABLE LOG DATA COMBINED WITH AVAILABLE DECISION TREE INFO, THE MOST PROBABLE CAUSE OF THE OVERFILL WAS DETERMINED TO BE INSUFFICIENT DRAIN/FALSE EMPTY DETECT AND USER ERROR, INAPPROPRIATE BYPASS OF A LOW DRAIN VOLUME ALARM.

    Description of Event or Problem · 1

    DURING EVAL OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECH IDENTIFIED A POTENTIAL OVERFILL SITUATION. DURING DRAIN 2 OF THERAPY ON (B) (6) 2007, THE HOME PT HAD AN ULTRAFILTRATION (UF) OF 562 ML FOLLOWING A FILL VOLUME OF 1500 ML, INDICATING THAT THE PT DRAINED 2062ML (1500+562=2062). NO FURTHER INFO REGARDING THIS EVENT COULD BE OBTAINED DESPITE A REQUEST BY BAXTER.

    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