BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4061451 · Received September 4, 2014

    Report

    Report Number
    1416980-2014-29603
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 10, 2014
    Report Date
    August 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 EVENT HISTORY LOG DID NOT VERIFY THE REPORTED EVENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND INDICATED THAT MANUFACTURE OF THE DEVICE IS NOT RELATED TO THE REPORTED EVENT. REVIEW OF SERVICE HISTORY DATA REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. VISUAL INSPECTION AND FUNCTIONAL TESTS WERE PERFORMED AND THE DEVICE MET PRODUCT SPECIFICATIONS. FULL FUNCTIONAL TESTING, ELECTRICAL SAFETY TESTING, CALIBRATION, AND SIMULATED THERAPY WERE PERFORMED WITH NO OTHER DEFECTS AND MALFUNCTIONS FOUND WITH THE DEVICE. SAMPLE ANALYSIS OF THE DEVICE WAS UNABLE TO VERIFY THE EVENT, AND UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE OF THE REPORTED EVENT WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN UNSPECIFIED FAILURE ON THE HOMECHOICE DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542866 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1