BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1882215 · Received October 26, 2010

    Report

    Report Number
    1423500-2010-04926
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE IS UNKNOWN; SHOULD THE PRODUCT CODE BE IDENTIFIED AT A LATER DATE OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) THAT OCCURRED DURING DWELL 3 OF 6 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT 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 CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) DURING DWELL 3 OF 6 ON THE HOMECHOICE (HC). THE HOME PATIENT (HP) WAS CONNECTED AT THE TIME OF THE ALARM AND HAD NOT DISCONNECTED PRIOR TO THE ALARM. ALL BAGS WERE PROPERLY SPIKED AND CONNECTED. NO PATIENT EXTENSION LINES WERE BEING USED AND THERE WERE NO OPEN CLAMPS ON ANY UNUSED SUPPLY LINES. THE CAUSE OF THE ALARM WAS UNDETERMINED. THE HP WAS ADVISED TO CLOSE ALL CLAMPS AND THE TRANSFER SET AND CYCLE THE POWER ON/OFF. THE HP WILL INFORM HIS PERITONEAL DIALYSIS NURSE THE NEXT MORNING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED WITH THIS EVENT.

    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