BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3936229 · Received July 15, 2014

    Report

    Report Number
    1416980-2014-22690
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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 AND EXTERNAL INSPECTIONS WERE PERFORMED AND FOUND AN UNRELATED ISSUE. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE PASSED. RITE (RETURNED INSTRUMENT TEST EVALUATION) ELECTRICAL TESTING WAS CONDUCTED AND THE DEVICE PASSED. THE DEVICE FAILED RITE FUNCTIONAL TESTING AS FLUID WAS TRANSFERRED ABOVE THE ALLOWABLE SPECIFICATION RANGE. A MANUAL VOLUMETRIC ACCURACY TEST WAS PERFORMED AND ALSO FAILED. FURTHER INSPECTION OF THE DOOR ASSEMBLY REVEALED AN INSUFFICIENT AMOUNT OF COPPER MESH. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE THE INSUFFICIENT AMOUNT OF COPPER MESH. THE DOOR PISTON WAS SCRAPPED, AND THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) WAS RETURNED AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP 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. THE DEVICE FAILED DURING EVALUATION WITH NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412247 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1