BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1971835 · Received January 27, 2011

    Report

    Report Number
    1423500-2011-01125
    Event Type
    Malfunction
    Date Received
    January 27, 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). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S. THE REPORTED CONDITION OF SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THEREFORE, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. SYSTEM ERROR 2240 IS BEING INVESTIGATED THROUGH RENQ-CAPA-(B)(4).

    Description of Event or Problem · 1

    A PATIENT CONTACTED BAXTER (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DWELL CYCLE 3. THE PATIENT WAS CONNECTED AND DID NOT DISCONNECT PRIOR TO THE ERROR. ALL OF THE BAGS WERE PROPERLY SPIKED AND CONNECTED. NO PATIENT EXTENSION LINES WERE USED. THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES AND NOTHING UNUSUAL NOTICED WITH THE SUPPLIES. THE PATIENT WAS ADVISED TO CONTACT THEIR NURSE IN THE MORNING. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CYCLER R5C8320