BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3926769 · Received July 10, 2014

    Report

    Report Number
    1416980-2014-22044
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 13, 2014
    Report Date
    June 16, 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). 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. RETURNED HOMECHOICE DEVICES RECEIVE A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDES FUNCTIONAL AND ELECTRICAL TESTING ON THE DEVICE. A REVIEW OF THE EVENT HISTORY LOG REVEALED SYSTEM ERRORS 2261, 2265, 2201, 2119, 2097. SYSTEM ERRORS 2201, 2047, 2114 AND 2261 WERE FOUND DURING SAMPLE EVALUATION. SYSTEM ERROR 2201 WAS DETERMINED TO BE VERIFICATION OF THE REPORTED PROBLEM AS IT APPEARED IN BOTH THE LOG AND DURING EVALUATION. FUNCTIONAL TESTING REVEALED THAT THE MANIFOLD O-RINGS AND TUBINGS DID NOT MEET PRODUCT SPECIFICATIONS AND THE MANIFOLD O-RINGS AND TUBINGS WERE REPLACED. FULL FUNCTIONAL TESTING, ELECTRICAL SAFETY TESTING, CALIBRATION, AND SIMULATED THERAPY WERE THEN 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 A HOMECHOICE (HC) PRO MACHINE EXPERIENCED AN UNSPECIFIED SYSTEM ERROR (SE). THIS OCCURRED DURING AN UNSPECIFIED STEP OF PERITONEAL DIALYSIS (PD) THERAPY. PATIENT CONNECTION AT THE TIME OF THE SE IS UNKNOWN. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403631 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1