BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1960708 · Received January 13, 2011

    Report

    Report Number
    1423500-2011-00585
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 24, 2010
    Report Date
    December 24, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR (SE) 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4). .

    Description of Event or Problem · 1

    A NURSE CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE PATIENT'S THERAPY. THE NURSE STATED THE PATIENT SOMETIMES DISCONNECTS AND MAY NOT REMEMBER. THE NURSE STATED THE PATIENT DOES NOT ALWAYS USE THE CAPS WHEN HE DISCONNECTS. THE NURSE EXPLAINED THE PATIENT HAD INFLUENZA AND THE PATIENT'S DIALYSIS NURSE TOLD HER TO HAVE THE PATIENT START THERAPY EARLY. GTS EXPLAINED THE ERROR INDICATED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE APD CYCLER