BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2901573 · Received January 8, 2013

    Report

    Report Number
    1416980-2013-00497
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REGARDING SYSTEM ERROR 2240 IN DRAIN 1 OF 5. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) HELPED THE CALLER END THERAPY AS THE HP STARTED OVER WITH THE SAME SUPPLIES FROM PREVIOUS THERAPY THAT ENDED DUE TO THE SYSTEM ERROR ALARM; THE CALLER WOULD DISCARD THE SUPPLIES. THE CALLER WOULD CONTACT THE RN (REGISTERED NURSE) REGARDING THE ALARM WHILE BEING CONNECTED. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. THE HP WOULD COMPLETE THERAPY WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9069 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE