BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1193497 · Received October 8, 2008

    Report

    Report Number
    1423500-2008-00860
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NURSE DID NOT WISH TO RETURN THE HOMECHOICE MACHINE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) NURSE CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THAT THE HOME PATIENT (HP) REPORTED TO HER THAT SHE FELT OVERFILLED THIS MORNING AFTER ABORTING THERAPY DUE TO A SYSTEM ERROR RECEIVED ON THE HOMECHOICE (HC) MACHINE IN DWELL 1. THE NURSE STATED THAT THE HP DID NOT CLOSE THE TRANSFER SET (CLAMP) OR DISCONNECT PRIOR TO OPENING THE CASSETTE DOOR AFTER ENDING THERAPY. THE TRANSFER SET CLAMP SHOULD BE CLOSED PRIOR TO OPENING THE CASSETTE DOOR AT THE END OF THERAPY. THE HP TURNED OFF THE HC, DISCONNECTED, AND WENT TO SLEEP. SHE WOKE UP THIS MORNING FEELING BLOATED. THE HP MANUALLY DRAINED OUT 4.4 L AND REPORTED THE INCIDENT TO HER PD NURSE. THE NURSE STATED THAT THE HP HAS NO DISCOMFORT AND DID NOT NEED MEDICAL TREATMENT. THE NURSE INSTRUCTED THE HP TO ALWAYS CALL BAXTER FOR ANY ALARM. THE HP WAS ON THE HC FOR THE FIRST NIGHT WHEN THE INCIDENT OCCURRED. THE PROGRAMMED FILL VOLUME FOR THIS HP IS 2000 ML. THE NURSE REPORTED THE HP WILL CONTINUE WITH THERAPY AND SHE WILL ASSIST WITH SETUP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. PRODUCT SURVEILLANCE CONTACTED THE HP'S CAREGIVER (CG) AND EXPLAINED PROPER PROCEDURE. THE CG WILL ENSURE THE HP IS AWARE OF CLOSING ALL CLAMPS BEFORE DISCONNECTING AND ENDING THERAPY. THE CG STATED THAT THE HP HAS NOT HAD PROBLEMS WITH THERAPY SINCE THIS INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE CYCLER-REFURBISHED NONE FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR