BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1053505 · Received May 28, 2008

    Report

    Report Number
    1423500-2008-00416
    Event Type
    Malfunction
    Date Received
    May 28, 2008
    Date of Event
    May 7, 2008
    Report Date
    May 7, 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

    THE DEVICE WAS REQUESTED FOR EVALUATION BUT HAD NOT BEEN RECEIVED AT THE TIME OF SUBMISSION OF THIS REPORT. A FOLLOW-UP WILL BE SUBMITTED WHEN EVALUATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING FEELING OVERFILLED IN DWELL 1 OF 4 OF THERAPY ON A HOMECHOICE DEVICE. THE PATIENT REPORTED DISCOMFORT, PAIN, DISTENSION AND SHORTNESS OF BREATH. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED WITH A MANUAL DRAIN AND DRAINED 4868ML. THE PATIENT'S LAST VOLUME INFUSED WAS 2900ML. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    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