BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3902533 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20848
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    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 RETURNED TO BAXTER AND AN EVALUATION WAS COMPLETED. A REVIEW OF THE EVENT LOG COULD NOT BE PERFORMED DUE TO SOFTWARE ISSUES. DURING EVALUATION, VISUAL INSPECTION AND FUNCTIONAL TESTING WERE ABLE TO REPLICATE THE REPORTED PROBLEM AND NOTED THAT THE DEVICE WAS UNABLE TO START UP PROPERLY. UPON CONCLUSION OF THE INVESTIGATION, IT WAS DETERMINED THAT THE CAUSE OF THE REPORTED ISSUE WAS FAULTY DIGITAL BOARD INTERNAL SOFTWARE EPROMS. THE INTERNAL SOFTWARE EPROMS WERE CHANGED AND THE DEVICE PASSED SUBSEQUENT TESTING. NO FURTHER ISSUES WERE WITH THE DISPLAY OR ALARMS WERE NOTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOMECHOICE (HC) PRO MACHINE EXPERIENCED AN UNKNOWN ALARM, WITH NO ERROR MESSAGE DISPLAYED. THIS OCCURRED BEFORE PATIENT USE, SO THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381245 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1