BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3913286 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21477
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE WAS RETURNED, AND A DEVICE ANALYSIS IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE EVALUATION OR IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) EVALUATION WAS COMPLETED. THE EVENT HISTORY LOG REVIEW SHOWED NO KEYSTROKES, PROGRAMMING, OR USE RELATED EVENTS THAT INDICATED AND/OR CONTRIBUTED TO THE REPORTED ISSUE. NO ABNORMALITIES WERE IDENTIFIED DURING INTERNAL/EXTERNAL INSPECTIONS. TEMPERATURE CONFIRMATION TESTING WAS PERFORMED AND THE DEVICE 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. FURTHER INSPECTION OF THE DOOR ASSEMBLY IDENTIFIED DETERIORATED PISTON FOAM AND A CRACKED DOOR PISTON ON THE RIB OF THE LEFT DISPOSABLE. TEST PISTON FOAM WAS INSTALLED AND THE DEVICE WAS ABLE TO PASS VOLUMETRIC ACCURACY TESTING. THE CAUSE OF THE RITE FAILURE WAS DUE TO THE DETERIORATED PISTON FOAM AND CRACKED DOOR PISTON. THE PISTON FOAM AND DOOR PISTON WAS SCRAPPED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING THE EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THAT THE DEVICE FAILED VOLUMETRIC ACCURACY TESTING. THERE WAS NO PATIENT INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389168 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1