BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1067259 · Received June 27, 2008

    Report

    Report Number
    1423500-2008-00557
    Event Type
    Malfunction
    Date Received
    June 27, 2008
    Date of Event
    February 1, 2008
    Report Date
    June 19, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). ADDITIONAL 510(K)#: K923065. EVALUATION SUMMARY: THE EVALUATION DID NOT CONFIRM ANY FAILURE OR MALFUNCTION OF THE DEVICE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS OVERFILL IDENTIFIED DURING EVALUATION. BASED ON A REVIEW OF THE AVAILABLE LOG DATA, IT WAS DETERMINED THAT THE PROBABLE CAUSE OF THIS OVERFILL WAS INSUFFICIENT DRAIN: FALSE EMPTY DETECT AT INITIAL DRAIN AND AT PREVIOUS THERAPY LAST DRAIN.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED A POTENTIAL OVERFILL SITUATION. DURING DRAIN 2 OF THERAPY IN (B) (6) 2008, A HOME PATIENT HAD AN ULTRAFILTRATION (UF) OF 651ML. THIS INDICATES THAT THE HOME PATIENT DRAINED 2651ML FOLLOWING A FILL VOLUME OF 2000ML (2000ML+651ML=2651ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1