BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3840780 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17404
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND AN EVALUATION WAS PERFORMED TO INVESTIGATE THE REPORTED EVENT. THE REPORTED EVENT WAS UNKNOWN, THEREFORE THE DEVICE LOGS AND THE SAMPLE EVALUATION COULD NOT VERIFY THE REPORTED EVENT. HOWEVER, A REVIEW OF THE EVENT HISTORY LOG AND SAMPLE EVALUATION IDENTIFIED A RELOAD THE SET 202 ALARM. THE DEVICE RECEIVED VISUAL INSPECTION, ELECTRICAL TESTING AND FUNCTIONAL TESTING. A SHORT SIMULATED THERAPY WAS PERFORMED WITH NO ISSUES NOTES. THE DEVICE PASSED CALIBRATION TESTING. THE CAUSE OF THE RELOAD THE SET 102 ALARM WAS DETERMINED TO BE DUE TO THE MEMBRANE GASKET. THE MEMBRANE GASKET WAS SCRAPPED AND THE DEVICE WAS SENT TO SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE PRO PRESENTED AN UNKNOWN SYSTEM ERROR. THE SPECIFIC ERROR WAS NOT REPORTED. THIS OCCURRED DURING SET-UP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317870 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1