BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3873122 · Received June 13, 2014

    Report

    Report Number
    1416980-2014-18970
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED VISUAL INSPECTION, SYSTEM CALIBRATIONS, A SIMULATED THERAPY, AND FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. UPON CONCLUSION OF THE INVESTIGATION, AN ISSUE WAS FOUND WITH THE DEVICE EPROMS SOFTWARE. THE EPROMS SOFTWARE WAS REPROGRAMMED. THE DEVICE WAS SERVICED AND RESTORED TO A GOOD WORKING CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) WAS RETURNED AND ANALYZED. THE EVENT HISTORY LOGS WERE UNABLE TO BE DOWNLOADED DUE TO A SOFTWARE FAILURE. AN UNRELATED ISSUE WAS FOUND DURING INTERNAL/EXTERNAL INSPECTIONS. FUNCTIONAL TESTING IDENTIFIED THAT THE HC SOFTWARE DID NOT MEET PRODUCT SPECIFICATIONS. THE DEVICE WAS ABLE TO UNDERGO A SIMULATED THERAPY WITH NO ISSUES NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN MALFUNCTION OCCURRED ON A HOMECHOICE (HC). THE REPORTER INDICATED THAT THE PROBLEM WAS DUE TO THE EPROM, BUT THE EXACT ISSUE 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
    349163 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1