BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4101854 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32220
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 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). THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED. THE HC UNDERWENT VISUAL EVALUATION AND ONE HOUR OF SIMULATED THERAPY WITH NO PROBLEMS FOUND. THE MACHINE HAD FULL FUNCTIONAL TESTING AND ELECTRICAL SAFETY TESTING WITH NO DEFECTS OR MALFUNCTIONS FOUND RELATED TO THE REPORTED ISSUE OF FLUID BEING OVER TEMPERATURE. THE OVER TEMPERATURE ISSUE WAS NOT VERIFIED THROUGH THE SAMPLE EVALUATION. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE SERVICE HISTORY REVEALED NO FAILURES OR PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO THE REPORTED CONDITION AND THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 THE FLUID WAS OVER HEATED ON THE HOMECHOICE PRO 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
    581682 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1