BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 3901436 · Received June 30, 2014

    Report

    Report Number
    1416980-2014-20788
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE HOMECHOICE (HC) WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. A SERVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY ISSUES IN THE PREVIOUS SERVICE EVENTS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HIGH DRAIN DURING CYCLE FOUR ALARM ON HOMECHOICE (HC) DURING USE WHILE PATIENT WAS NOT CONNECTED. THE REGISTERED NURSE (RN) JUST WANTED TO ASK HOW TO CLEAR THE MESSAGE AND THE RN WAS AWARE OF THE DRAIN VOLUME. TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED HOW TO CLEAR THE MESSAGE, AND ADVISED RN HOW TO CONTINUE TO SET UP FOR THERAPY. THE HC WAS OPERATIONAL AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381009 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1