BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4100214 · Received September 18, 2014

    Report

    Report Number
    1416980-2014-32105
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. THE DEVICE PASSED THE ONE HOUR THERAPY AND THERE WERE NO ISSUES NOTED. THE DEVICE COMPLETED THE ELECTRICAL SAFETY TEST AND THE FUNCTIONAL CHECK. A REVIEW OF THE SERVICE HISTORY HAD NO PREVIOUS SERVICE HISTORY THAT CONTRIBUTED TO THE CURRENT REPORTED PROBLEM. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED EVENT. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY FOUND THAT THE DEVICE WAS NO LONGER IN ITS ORIGINAL MANUFACTURED CONDITION. THE REPORTED PROBLEM COULD NOT BE VERIFIED THROUGH EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN HAVING ISSUES WITH THE HOMECHOICE (HC) DEVICE. THE REGISTERED NURSE STATED THAT THE HC WAS NOT FUNCTIONING PROPERLY, BUT THE PROBLEM WAS NOT SPECIFIED. 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
    578776 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1