BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3850463 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-17963
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED AND ANALYZED. THE REPORTED HIGH DRAIN ALARM WAS VERIFIED DURING AN EVENT HISTORY LOG REVIEW. NO ABNORMALITIES WERE IDENTIFIED DURING INTERNAL AND EXTERNAL INSPECTIONS. THE DEVICE PASSED ALL FUNCTIONAL TESTING, AND IT WAS ABLE TO PERFORM A SIMULATED THERAPY SUCCESSFULLY. ALTHOUGH FOUND IN THE LOGS, THE HIGH DRAIN ALARM WAS UNABLE TO BE DUPLICATED, AND NO NONCONFORMING PRODUCT WAS FOUND DURING SAMPLE ANALYSIS. THE CAUSE OF THE HIGH DRAIN ALARM WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS REPORTED TO BE AVAILABLE FOR RETURN BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH DRAIN 108 ALARM OCCURRED DURING USE ON THE HOME CHOICE (HC). THIS INDICATES THE PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED THE RETURN OF THE DEVICE. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330306 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1