BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3944912 · Received July 18, 2014

    Report

    Report Number
    1416980-2014-23336
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BUT THE EVALUATION HAS YET TO BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER, AND THE EVALUATION IS COMPLETE. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. INTERNAL/EXTERNAL INSPECTIONS WERE PERFORMED AND FOUND AN INFESTATION. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE PASSED. RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TESTING WAS CONDUCTED AND THE DEVICE PASSED. THE DEVICE ALSO FAILED RITE FUNCTIONAL TESTING AS FLUID WAS TRANSFERRED ABOVE THE ALLOWABLE SPECIFICATION RANGE. FURTHER INSPECTION OF THE DOOR ASSEMBLY REVEALED DETERIORATED PISTON FOAM. THE CAUSE OF THE RITE FAILURE WAS DUE TO THE DETERIORATED PISTON FOAM. THE ENTIRE DEVICE WAS SCRAPPED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED FLUID VOLUME ACCURACY TESTING. DEVICE FAILED DURING EVALUATION, NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421332 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1