BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1844551 · Received September 27, 2010

    Report

    Report Number
    1423500-2010-03733
    Event Type
    Malfunction
    Date Received
    September 27, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. NO USE ERROR WAS SUSPECTED THEREFORE NO LABEL REVIEW WAS REQUIRED.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).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR BECAUSE THE PRODUCT INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR 2240 ALARM (INDICATING AIR) ON THE HOMECHOICE DEVICE DURING USE. THE HOME PATIENT (HP) STATED HER PATIENT LINE WASN'T CONNECTED TIGHT AND IT CAME LOOSE AND THE BED WAS WET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND HAD THE HP CLOSE ALL CLAMPS AND THE TRANSFER THE SET. THE TSR ADVISED THE HP TO DISCARD ALL SUPPLIES AND TO REPORT ALARMS TO THE PERITONEAL DIALYSIS NURSE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1