BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4103255 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32426
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. REVIEW OF THE EVENT HISTORY LOG VERIFIED THE EVENT. VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED. FULL FUNCTIONAL TESTING, ELECTRICAL SAFETY TESTING, CALIBRATION AND SIMULATED THERAPY WERE PERFORMED WITH NO ADDITIONAL DEFECTS AND MALFUNCTIONS FOUND WITH THE DEVICE. SAMPLE ANALYSIS VERIFIED THE REPORTED EVENT AS SYSTEM ERROR 2261, SYSTEM ERROR 0003, AND SYSTEM ERROR 2401, RELATED TO SOFTWARE ERROR AND THE EPROM KIT WAS REPLACED. SAMPLE ANALYSIS DID NOT FIND ANY OTHER DEFECTS DURING THE EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED FAILURE OCCURRED DURING USE ON THE HOMECHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582311 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1