BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3013762 · Received March 20, 2013

    Report

    Report Number
    1416980-2013-06773
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CONDITION COULD NOT BE CONFIRMED, AS THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER FOR EVALUATION. THEREFORE THE CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A SYSTEM ERROR (SE) 2240 DURING PERITONEAL DIALYSIS (PD) THERAPY. THIS OCCURRED WHILE THE HOME PATIENT (HP) WAS CONNECTED, DURING DWELL. THE HP STATED THAT THERE WAS NOTHING UNUSUAL NOTED ABOUT THE SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM WITH THE HP, ASSISTED THEM WITH TROUBLESHOOTING, AND ADVISED THEM TO START OVER WITH ALL NEW SUPPLIES. PROPER PROCEDURES, PER THE USER MANUAL, WERE REVIEWED WITH THE HP. THERE WAS PATIENT INVOLVEMENT, HOWEVER THERE WAS NO PATIENT INJURY NOR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116763 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE