BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1423500-2011-11985

    MDR report key: 2241811 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-11985
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510K NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT AND LOT NUMBER IS UNKNOWN.THE SAMPLE IS NOT AVAILABLE. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FOR A CHECK PATIENT LINE ALARM WITH AIR IN THE PATIENT LINE. THE COMPLAINT WAS NOT CONFIRMED. THE CAUSE OF THE ALARM AND AIR WAS UNDETERMINED BECAUSE THE SAMPLE WAS NOT RETURNED FOR EVALUATION. 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.

    Description of Event or Problem · 1

    THIS REPORT IS FOR ISSUE OF AIR IN PATIENT LINE. THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT A CHECK PATIENT LINE WHICH OCCURRED ON HOME CHOICE (HC) ON DURING USE DURING INITIAL DRAIN. THE HOME PATIENT (HP) STATED THE HP WAS CONNECTED AT THE TIME OF THE ALARM AND STATED THAT THERE WAS LARGE AMOUNT OF AIR IN THE PATIENT LINE. THE BAXTER TECHNICAL REPRESENTATIVE (TSR) ASSISTED THE HP TO END THERAPY AND RESTART THERAPY WITH NEW DISPOSABLES. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1