BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED

    MDR report key: 986031 · Received January 17, 2008

    Report

    Report Number
    1423500-2008-00027
    Event Type
    Malfunction
    Date Received
    January 17, 2008
    Date of Event
    December 21, 2007
    Report Date
    December 21, 2007
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K012988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HP WAS ASKED TO SWAP THE DEVICE AND REFUSED.

    Description of Event or Problem · 1

    A HUSBAND CONTACTED A BAXTER TECHNICAL SVC REP (TSR) REGARDING THE MACHINE WENT STRAIGHT INTO FILL 1 WITHOUT DRAINING THE HOME PT (HP). THE HUSBAND ALSO STATED THE HP DOES A MANUAL FILL OF 2000ML DURING THE DAY. THE TSR HAD HUSBAND CHECK THE PROGRAM AND FOUND THE INITIAL ALARM (IDA) = 0ML, AND DV FOR THE INITIAL DRAIN CYCLE = 10ML. AFTER INITIAL DRAIN, THE FILL VOLUME DURING FILL 1 WAS 2129ML. THE HP FELT OK AND HAD NO SYMPTOMS OF OVERFILL. THE TSR HAD THE HUSBAND PRESS THE STOP BUTTON ON THE MACHINE AND HAD THE HP GO INTO A MANUAL DRAIN. THE HP DRAINED 4149ML AFTER ABOUT 35 MINS. THE TSR BYPASSED THE HP TO FILL 2 AND THE HP WAS FILLING AS EXPECTED. TSR ADVISED HUSBAND TO CONTACT PD RN AS SOON AS POSSIBLE TO HAVE THE IDA CHANGED TO AVOID AN OVERFILL SITUATION AND ALSO ADVISED HIM TO DO A MANUAL DRAIN BEFORE CONNECTING HP TO MACHINE TOMORROW IF RN IS UNAVAILABLE. THE HOMECHOICE WAS OPERATIONAL. A FOLLOW-UP WITH THE RN REVEALED THAT SHE WAS AWARE OF THE REPORTED OVERFILL AND HAS CHANGED THE IDA. THE RN COULD NOT RECALL WHAT SHE CHANGED THE IDA TO. NO PT INJURY OR MEDICAL INTERVENTION WAS ASSOCIATED WITH THIS INCIDENT PER THE RN.

    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