BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 4232880 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39157
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NOTHING FOUND IN THE EVENT LOGS THAT WOULD INDICATE THE RITE FAILURE. REVIEW OF SERVICE HISTORY DATA REVEALED PREVIOUS DEVICE SERVICING DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. THE HOMECHOICE (HC) DEVICE WAS RETURNED AND EVALUATED BY THE PRODUCT ANALYSIS LAB (PAL). THE DEVICE FAILED VOLUMETRIC ACCURACY TESTING. EXTERNAL/INTERNAL INSPECTION WAS PERFORMED AND PASSED. A VOLUMETRIC ACCURACY TEST WAS PERFORMED AND THE DEVICE FAILED. TEMPERATURE WAS WITHIN SPECIFICATIONS. AN INSPECTION OF THE DOOR ASSEMBLY REVEALED THE DOOR PISTON WAS CRACKED AND THE DOOR PISTON FOAM DETERIORATED. THE CAUSE FOR THE FAILED VOLUMETRIC ACCURACY TEST WAS DETERMINED TO BE THE CRACKED DOOR PISTON AND THE DETERIORATED DOOR PISTON FOAM. PAL RECOMMENDS SCRAPPING THE PISTON AND DOOR PISTON FOAM. THE DEVICE WAS SENT TO SERVICE. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712805 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1