BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3760794 · Received April 21, 2014

    Report

    Report Number
    1416980-2014-12768
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 27, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION. DURING FUNCTIONAL TESTING THE DEVICE EXPERIENCED A CONTINUOUS BEEPING. THE EVENT LOGS WERE UNABLE TO BE DOWNLOADED TO THE ISSUE. THE UNKNOWN PROBLEM REPORTED WAS VERIFIED DURING THE SAMPLE ANALYSIS AS THE DEVICE EXPERIENCED A CONTINUOUS BEEPING. THE CAUSE OF THE ISSUE WAS DETERMINED TO BE FAULTY EPROMS. THE EPROMS WERE REPROGRAMMED TO ADDRESS THE PROBLEM. THE DEVICE WAS SENT FOR SERVICING. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). THE DEVICE HAS BEEN RECEIVED BY BAXTER AND IS CURRENTLY AWAITING 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 EVALUATED. THE DEVICE UNDERWENT ELECTRICAL AND FUNCTIONAL TESTING AND A VISUAL INSPECTION. THE REPORTED EVENT COULD NOT BE VERIFIED THROUGH THE SAMPLE EVALUATION BECAUSE THE TYPE OF EVENT REPORTED WAS UNKNOWN. THE EVENT HISTORY LOG COULD NOT BE DOWNLOADED DUE TO AN UNRELATED ISSUE. TESTING SPECIFICATIONS FOR THIS DEVICE WERE MET DURING PREVIOUS SERVICE EVENTS AND THE PREVIOUS SERVICING DID NOT CONTRIBUTE TO THE REPORTED PROBLEM. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE PRO HAD AN UNKNOWN PROBLEM. THE SPECIFIC ISSUE WAS NOT REPORTED. IT WAS NOT SPECIFIED WHEN IN THE THERAPY THIS OCCURRED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240018 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1