BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4130917 · Received September 30, 2014

    Report

    Report Number
    1416980-2014-33963
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE WAS RETURNED AND IN THE PROCESS OF BEING EVALUATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). AN EXTERNAL/INTERNAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE WAS DETERMINED TO MEET ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE (RETURNED INSTRUMENT TEST EVALUATION) TESTING. THE DEVICE FAILED RITE FUNCTIONAL TESTING AS FLUID WAS TRANSFERRED BELOW THE ALLOWABLE SPECIFICATION RANGE DURING VOLUMETRIC ACCURACY TESTING. A MANUAL VOLUME ACCURACY TEST WAS PERFORMED AND THE DEVICE PASSED. THE DEVICE WAS DETERMINED TO MEET PRODUCT SPECIFICATIONS RELATED TO THE FAILURE. REVIEW OF THE DEVICE LOGS DID NOT VERIFY THE ADDITIONAL ISSUE OF A RITE FUNCTIONAL VOLUMETRIC ACCURACY TEST FAILURE. A SERVICE HISTORY REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS NOTED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT DURING THE SERVICE OF THIS DEVICE. UPON CONCLUSION OF THE INVESTIGATION, A CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. 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. THE DEVICE FAILED DURING EVALUATION WITH NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607975 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1