BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4840971 · Received June 12, 2015

    Report

    Report Number
    1416980-2015-25022
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 1, 2015
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AN INTERNAL/EXTERNAL INSPECTION WAS PERFORMED AND THE DEVICE PASSED. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE). THIS EVALUATION INCLUDED FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE. DURING THE EVALUATION, THE FLUID WAS TRANSFERRED OUTSIDE OF THE RITE SPECIFIED LIMITS AND THE VOLUMETRIC ACCURACY TEST THAT FOLLOWED, SHOWED THAT THE DEVICE HAD FAILED. PAL PERFORMED A MORE DETAILED INSPECTION OF THE DOOR ASSEMBLY. THE INSPECTION SHOWED THAT THE PISTON FOAM WAS DETERIORATED. THE RESULTS OF THE EVALUATION REVEALED THE CAUSE OF THE FAILURE TO BE THE DETERIORATED PISTON FOAM. THE PISTON FOAM WAS TO BE 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 DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, A BAXTER TECHNICIAN DETERMINED THE DEVICE FAILED FLUID VOLUME ACCURACY TESTING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386482 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1