BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1003768 · Received February 22, 2008

    Report

    Report Number
    1423500-2008-00095
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 24, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HOME PATIENT'S (HP) DAUGHTER REPORTED AN OVERFILL TO PRODUCT SURVEILLANCE. DURING A FOLLOW UP, THE HP REPORTED HE WAS EXPERIENCING SWELLING IN HIS LEGS AS WELL AS SHORTNESS OF BREATH AT THE TIME OF THE INCIDENT. HISTORICALLY, THE HP ADMITTED TO TURNING THE HOMECHOICE MACHINE OFF TO SILENCE ALARMS RATHER THAN CALLING TECHNICAL SERVICES, EVEN IF THERAPY WAS NOT YET COMPLETED. HE REALIZES NOW THAT HE NEEDS TO MAKE SURE HE IS FULLY DRAINED BEFORE STARTING A NEW THERAPY SESSION. THE NURSE AT THE DIALYSIS CLINIC REPORTED THAT THIS HP DRAINED 3500 ML WHEN HE WAS IN THE CLINIC ON THE DATE THE OVERFILL OCCURRED (2008). HIS REGULAR FILL VOLUME IS 2000 ML. THE NURSE REPORTED THAT SHE BELIEVES THIS HP MAY HAVE BYPASSED DRAIN CYCLES AS WELL AS ENDING THERAPY EARLY BY TURNING OFF THE MACHINE WHEN ALARMING. SHE HAS SINCE REINSTRUCTED THE HP ON PROPER PROCEDURES AND BELIEVES HE UNDERSTANDS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    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