BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0707 ARENA MACHINE 2 PUMPSWITH NIBP

    MDR report key: 1001126 · Received February 15, 2008

    Report

    Report Number
    1423500-2008-00088
    Event Type
    Malfunction
    Date Received
    February 15, 2008
    Date of Event
    January 17, 2008
    Report Date
    January 18, 2008
    Manufacturer
    BAXTER HEALTHCARE
    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 2007 AND NO ANOMALIES RELATED TO THE UF HAD BEEN REPORTED. BAXTER IS MONITORING ISSUES LIKE THIS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A FOREIGN COUNTRY REPORTED A FAILURE INVOLVING THE ARENA HEMODIALYSIS MACHINE. A PATIENT CONNECTED TO THE AFFECTED DEVICE DURING TREATMENT ON THE MORNING OF 2008 REPORTEDLY EXPERIENCED A DROP IN BLOOD PRESSURE. THE PATIENT REPORTEDLY SUFFERED SHOCK DUE TO A LOW BLOOD PRESSURE. THE CLINIC FOLLOWED STANDARD PROCEDURES TO RESOLVE THE DROP OF THE BLOOD PRESSURE. NO ADDITIONAL PROBLEMS WERE REPORTED. THE PATIENT WAS DISCHARGED TO HOME. DURING THREE TREATMENTS WITH THIS DEVICE MORE ULTRAFILTRATION (UF) THAN THE ESTABLISHED PROGRAM OCCURRED. THE DEVICE HAD BEEN USED FOR THREE HD TREATMENTS BEFORE BEING REMOVED FROM SERVICE AND REPORTED TO THE FST. IN THE THREE TREATMENTS (TWO DAYS IN 2008 ), THE DEVICE REMOVED 500-600 G MORE THAN THE UF TARGET PROGRAMMED. IN THE SECOND OF THE THREE TREATMENTS THIS PATIENT EVENT OCCURRED. ONE MORE TREATMENT WAS COMPLETED WITH THIS DEVICE WITHOUT FURTHER INCIDENT TO A PATIENT. NO RELATED ALARMS TO THE UF WERE REPORTED DURING THE TREATMENTS. THE FACILITY DECLINED TO PROVIDE ADDITIONAL INFORMATION. THE FOREIGN MEDICAL DIRECTOR INDICATES: TAKING THE ADDITIONAL INFORMATION RECEIVED IT SEEMS THAT THE CASE WILL PROBABLY HAVE TO BE DOWNGRADED TO 30-DAY REPORT AND THAT THE MOST APPROPRIATE CODE IS INDEED "HIGH ULTRAFILTRATION". IT SEEMS THAT THE PATIENT EXPERIENCED SIMPLY A BLOOD PRESSURE DROP BUT NO HYPOVOLEMIC SHOCK, WHICH IS MORE IN LINE WITH THE REPORTED PROBLEM (500-600ML EXCESSIVE UF).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1