BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1053490 · Received May 28, 2008

    Report

    Report Number
    1423500-2008-00425
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    March 3, 2008
    Report Date
    May 14, 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

    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 THE EVALUATION. BASED ON A REVIEW OF THE DEVICE LOG DATA, IT WAS DETERMINED THAT THE PROBABLE CAUSE OF THIS OVERFILL WAS INSUFFICIENT DRAIN / MULTIPLE CYCLES ADVANCED TO FILL WHEN SLOW/NO FLOW CONDITION OCCURRED ABOVE THE MINIMUM DRAIN VOLUME THRESHOLD.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN IDENTIFIED A POTENTIAL OVERFILL SITUATION. DURING DRAIN 3 OF THERAPY IN 2008, THE PATIENT HAD AN ULTRAFILTRATION (UF) OF 980ML FOLLOWING A FILL VOLUME OF 1200ML. THE NURSE STATED THAT SHE WAS AWARE THAT THIS PATIENT FREQUENTLY HAS SMALL DRAINS FOLLOWED BY LARGE DRAIN VOLUMES AND STATED IT WAS NORMAL FOR THIS PATIENT. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF OVERFILL. THE NURSE WAS UNABLE TO PROVIDE FURTHER INFORMATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    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