BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3914363 · Received July 3, 2014

    Report

    Report Number
    1416980-2014-21585
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 11, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE EVALUATION WAS COMPLETED. ALTHOUGH THE REPORTED EVENT WAS NOT SPECIFIED, THE EVALUATION REVEALED IT TO BE A RELOAD THE SET (RLS) 152 ALARM. IT WAS VERIFIED THROUGH THE EVENT HISTORY LOG REVIEW AND SAMPLE EVALUATION. THE CAUSE WAS DETERMINED TO BE A LEAK IN THE MANIFOLD TUBING. THE TUBING WAS REPLACED AS THE DEVICE WAS SENT TO SERVICING. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE ALARM LOG REVEALED AN ALARM THAT VERIFIED THE REPORTED CONDITION. THE DEVICE WAS VISUALLY INSPECTED WITH NO ISSUES NOTED. FUNCTIONAL TESTS WERE PERFORMED ON THE DEVICE, AND IT FAILED THE CRT TEST. THE DEVICE WAS REPAIRED, AND THE DEVICE PASSED FUNCTION, ELECTRICAL SAFETY, CALIBRATION, AND SIMULATED THERAPY WITHOUT ADDITIONAL DEFECTS OR MALFUNCTIONS SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED UNKNOWN SYSTEM ERROR ALARMS ON THE HOMECHOICE DEVICE WHILE PERFORMING PERITONEAL DIALYSIS THERAPY (DETAILS NOT PROVIDED). NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390434 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1