BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3802947 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-15000
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 15, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION, FUNCTIONAL TESTING, AN EVENT HISTORY LOG REVIEW, AND A SHORT SIMULATED THERAPY WERE PERFORMED. A REVIEW OF THE DEVICE HISTORY DID NOT REVEAL ANY ISSUES RELATED TO THE REPORTED CONDITION. DURING FUNCTIONAL TESTING AND THE EVENT HISTORY LOG REVIEW, A POWER FAILURE WAS DETECTED. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE THE ACCOMP PRINTED CIRCUIT BOARD. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME 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
    280688 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1