BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 4161978 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35270
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    August 7, 2014
    Report Date
    September 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    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). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED ISSUE. AN INTERNAL AND EXTERNAL INSPECTION WAS PERFORMED AND IT PASSED. A SIMULATED THERAPY WAS PERFORMED AND THE DEVICE PASSED. THE DEVICE PASSED BOTH THE HOMECHOICE RITE (RETURN INSTRUMENT TEST/EVALUATION) ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. A REVIEW OF THE DEVICE LOG VERIFIED THE REPORTED PROBLEM OF IIPV. HOWEVER THERE WAS NOT ENOUGH INFORMATION TO DETERMINE THE DIRECT CAUSE. 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. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2015 DURING A MANUAL DOWNLOAD OF THE DEVICE LOGS A HIGH DRAIN VOLUME ERROR 104 WAS FOUND IN THE ALARM LOGS ONLY WHICH OCCURRED ON 08/07/14 AT 08:10. THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643787 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR