BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3802936 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15003
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND THE EVALUATION IS COMPLETE. A REVIEW OF THE EVENT LOG WAS PERFORMED WITH THE REPORTED ISSUE BEING IDENTIFIED. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONAL TESTING WAS PERFORMED WITH THE ISSUE OF NO POWER NOTED. ELECTRICAL SAFETY TESTING, CALIBRATION, AND A SIMULATED THERAPY WERE PERFORMED. THE CAUSE WAS DETERMINED TO BE A POWER SUPPLY FUSE. THE FUSE WAS 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). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. IF THE HOMECHOICE (HC) IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNKNOWN DEFECT OCCURRED ON A HOMECHOICE (HC) DEVICE BEFORE USE. THE DEFECT OCCURRED AFTER A SHORT CIRCUIT OCCURRED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280794 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1