BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1962543 · Received January 18, 2011

    Report

    Report Number
    1423500-2011-00714
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION. A 510K NUMBER CANNOT BE PROVIDED IN THIS REPORT BECAUSE THE PRODUCT CODE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING A DWELL CYCLE. THE PATIENT WAS CONNECTED AT THE TIME OF THE ERROR AND DID NOT DISCONNECT AT ANY TIME PRIOR TO THE ERROR. ALL OF THE BAGS WERE PROPERLY SPIKED AND CONNECTED, AND NO PATIENT EXTENSION LINES WERE IN USE. THERE WERE ALSO NO OPEN CLAMPS ON THE UNUSED SUPPLY LINES. THE PATIENT DID NOT REPORT ANYTHING UNUSUAL WITH THE SUPPLIES. GTS ASSISTED THE PATIENT IN ENDING THERAPY AND ADVISED THE PATIENT TO FINISH THERAPY MANUALLY OR START OVER WITH NEW SUPPLIES. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE APD CYCLER 220-240 VOLT (B)(4)