BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2970470 · Received February 20, 2013

    Report

    Report Number
    1416980-2013-04288
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. THE REPORTED PROBLEM WAS NOT REPRODUCED DURING FUNCTIONAL TESTING. THE REPORTED ISSUE WAS CONFIRMED IN THE EVENT HISTORY LOG REVIEW. THE CAUSE WAS DETERMINED TO BE UNEXPECTED HIGH UF FOR THERAPY. A DEVICE HISTORY REVIEW AND SERVICE HISTORY REVIEW WERE PERFORMED WITH NO ISSUES THAT COULD CONTRIBUTE TO THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. HOWEVER, THE SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION AS OF YET. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IIPV EVENT OCCURRED WITH A HOMECHOICE MACHINE DURING PERITONEAL DIALYSIS (PD) THERAPY, DURING DWELL 6 OF 6. THE HOME PATIENT (HP) STATED THE MACHINE ALARMED HIGH DRAIN 201 (PATIENT DRAINED GREATER THAN 200% OF THE MAXIMUM PRESCRIBED CYCLE FILL VOLUME IN STANDARD MODE) AT THE END OF THERAPY. THE COMPANY REPRESENTATIVE ASKED THE HP IF THEY FELT OVERFILLED AND THE HP STATED YES. THERE WAS PATIENT INVOLVEMENT, BUT NO CLINICAL CONSEQUENCES FOR THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74933 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1