BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL ULTRA FLUSHMOUNT FLOWMETER

    MDR report key: 13981241 · Received April 1, 2022

    Report

    Report Number
    2020813-2022-00003
    Event Type
    Malfunction
    Date Received
    April 1, 2022
    Date of Event
    March 3, 2022
    Report Date
    April 1, 2022
    Manufacturer
    ACCUTRON, INC.
    Product Code
    BSZ
    UDI-DI
    00813830020885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DIGITAL ULTRA FLUSHMOUNT FLOWMETER WAS RETURNED TO ACCUTRON FOR EVALUATION AND WAS FOUND TO BE OPERATING PROPERLY. NO ISSUES WERE NOTED. THROUGH FOLLOW-UP TESTING WITH FACILITY PERSONNEL, IT WAS FOUND THAT THE USER FACILITY'S NITROUS AND OXYGEN GAS LINES WERE SET UP INCORRECTLY BY THE THIRD-PARTY PLUMBING CONTRACTOR CAUSING THE WRONG GAS TO BE INPUT INTO THE FLOWMETER. THE FLOWMETER WAS INSTALLED IN (B)(6) 2022 AND HAD ONLY BEEN USED A FEW TIMES PRIOR TO THE REPORTED EVENT. THE USER FACILITY SHOULD HAVE PERFORMED THE OXYGEN FAILSAFE TEST PRIOR TO INITIAL USE OF THE FLOWMETER. THE DIGITAL ULTRA FLOWMETER USER MANUAL STATES (2), "WARNINGS VERIFY THAT THE CORRECT GASES ARE BEING DELIVERED TO THE CORRECT FLOWMETER INLETS BY PERFORMING THE OXYGEN FAILSAFE TEST IN SECTION VII." THE USER MANUAL FURTHER STATES (24), "OXYGEN FAILSAFE / CROSSED LINE TEST CHECK PRIOR TO FIRST USE, WHEN METER IS MOVED, OR MONTHLY SET FLOW TO 8 LPM TOTAL FLOW AND 50% N2O AND THEN SHUT OFF ALL OXYGEN CYLINDERS. UNIT SHOULD GO INTO OXYGEN FAILURE ALARM AND N2O FLOW SHOULD STOP. NOTE: THIS MAY TAKE A FEW MINUTES FOR LARGE CENTRAL SYSTEMS TO USE UP GAS IN O2 PASSAGES. IF GAS CONTINUES TO FLOW, N2O GAS MAY BE COMING IN ON OXYGEN LINES OR CIRCUIT BOARD COULD BE DAMAGED. DISCONTINUE USE IMMEDIATELY AND CONTACT CROSSTEX AS PATIENTS COULD SUFFER SEVERE INJURY." THE USER FACILITY STATED THAT THEY WOULD CONTACT THE THIRD-PARTY PLUMBING CONTRACTOR THAT INSTALLED THE GAS LINES TO ADDRESS THE ISSUE PRIOR TO RETURNING THE FLOWMETER TO SERVICE. ACCUTRON COUNSELED USER FACILITY PERSONNEL ON THE PROPER USE AND OPERATION OF THE DIGITAL ULTRA FLOWMETER SPECIFICALLY PERFORMING PROPER START UP TESTING INCLUDING THE OXYGEN FAILSAFE TEST. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT DURING TWO SEPARATE PATIENT PROCEDURES INVOLVING THE DIGITAL ULTRA FLUSHMOUNT FLOWMETER, ONE PATIENT BEGAN TO VOMIT AND ANOTHER BECAME UNRESPONSIVE. THE PATIENTS WERE ADMINISTERED OXYGEN AND FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1228021 DIGITAL ULTRA FLUSHMOUNT FLOWMETER FLOWMETER BSZ ACCUTRON, INC. 27076 00813830020885

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown