BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 1062808 · Received June 17, 2008

    Report

    Report Number
    1423500-2008-00497
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE HOMECHOICE (HC) MACHINE WAS NOT DRAINING OUT ALL THE FLUID. THE HOME PATIENT (HP) WANTED A SWAP OF THE HC MACHINE FOR THIS ISSUE. THE ULTRAFILTRATION (UF) READING AT THE TIME OF THE CALL WAS -290 ML AND THE HP REPORTED SHE DRAINED OUT 1400 ML MANUALLY AFTER THERAPY WAS COMPLETED. THE HP STATED THERE WAS NO ALARM ON THE MACHINE AND THIS IS THE FIRST TIME SHE'S DRAINED 1400 ML AFTER THERAPY. THE MOST SHE HAD DRAINED PREVIOUSLY WAS 400 ML AT THE END OF THERAPY. THE HC MACHINE IS NOT PROGRAMMED FOR A LAST FILL (LAST FILL VOLUME = 0 ML) AND THE HP DID NOT UNDERSTAND HOW THERE WAS 1400 ML OF SOLUTION INSIDE OF HER. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE MINIMUM DRAIN PERCENTAGE AND THE LAST MANUAL DRAIN OPTION ON THE HC MACHINE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    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