BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOME CHOICEPRO

    MDR report key: 2220371 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11094
    Event Type
    Malfunction
    Date Received
    August 23, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND EVALUATED. THE DEVICE FAILED EARTH LEAKAGE CURRENT TEST. THE ASSIGNABLE CAUSE OF EARTH LEAKAGE CURRENT TEST FAILED WAS DETERMINED TO BE BROKEN COMPRESSOR WIRE. A REVIEW OF THE PREVIOUS SERVICE RECORD, (B)(4) 2011, SHOWS THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO ITS RELEASE FROM THE TAMPA BAY FACILITY. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE ISSUES OF EARTH LEAKAGE CURRENT FAILURE. THE DAMAGE COMPONENTS WERE SCRAPPED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE (HC) DEVICE, A BAXTER TECHNICIAN DETERMINED THE HC MACHINE FAILED THE EARTH LEAKAGE CURRENT TEST. THERE IS NO PATIENT INVOLVEMENT, INJURY OR MEDICAL INTERVENTION AS THIS WAS FOUND DURING SERVICE AND TESTING

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1