BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0707 ARENA MACHINE 2 PUMPSWITH NIBP

    MDR report key: 1001125 · Received February 15, 2008

    Report

    Report Number
    1423500-2008-00089
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 16, 2008
    Report Date
    January 18, 2008
    Manufacturer
    BAXTER HEALTHCARE CORPORATION- LARGO
    Product Code
    KDI
    PMA / PMN Number
    K030099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE TECHNICIAN PERFORMED AN EVALUATION OF THE DEVICE ON-SITE. DURING THE ASSESSMENT, THE DEVICE ALARMED DURING THE SELF-TEST. TRANSMEMBRANE PRESSURE (TMP) UNSTABLE. THE TECHNICIAN CHANGED THE UF FLOW METER DIAPHRAGM AND CALIBRATED THE UF. NO PROBLEM WAS DETECTED IN THE HYDRAULIC OF THE SYSTEM (NO LEAKS OR DEFECTIVE PARTS). THE DEVICE WAS PLACED BACK INTO SERVICE. NO FURTHER ISSUES HAVE BEEN REPORTED. THIS DEVICE WAS INSTALLED 8-8-2007 AND NO ANOMALIES RELATED TO THE UF HAD BEEN REPORTED. BAXTER IS MONITORING ISSUES LIKE THIS. SHOULD SIGNIFICANT INFO BECOME AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A CASE REPORTED BY A FOREIGN COUNTRY ABOUT AN INCIDENT: THE DEVICE PERFORMED THREE HD TREATMENTS BEFORE THE OPERATOR REMOVED IT FROM THE SERVICE AND GAVE THE REPORT TO THE BIOMEDICAL TECHNICIAN. IN THE THREE TREATMENTS THE DEVICE REMOVED 500-600 G MORE THAN THE UF TARGET PROGRAMMED BY THE OPERATOR. THIS REPORT IS THE FIRST OF THREE TREATMENTS. THE FACILITY HAS NOT SHARED ANY FURTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0707 ARENA MACHINE 2 PUMPSWITH NIBP 78KDI KDI BAXTER HEALTHCARE CORPORATION- LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1