BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3943508 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23197
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 23, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED FOR EVALUATION. A REVIEW OF THE DEVICES LOGS VERIFIED THE REPORTED EVENT. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED VERIFICATION OF THE REPORTED EVENT AND DETERMINED TO BE THAT THE DEVICE NEEDED NEW CALIBRATION. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. INTERNAL & EXTERNAL VISUAL INSPECTIONS WERE PERFORMED. FULL FUNCTIONAL TESTING, ELECTRICAL SAFETY TESTING, CALIBRATION, AND SIMULATED THERAPY WAS PERFORMED WITH NO ADDITIONAL DEFECTS AND MALFUNCTIONS FOUND WITH THE DEVICE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED SYSTEM ERRORS OCCURRED DURING USE OF THE HOME CHOICE. 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
    422820 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1