BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWMETER

    MDR report key: 8553905 · Received April 26, 2019

    Report

    Report Number
    9611500-2019-00133
    Event Type
    Malfunction
    Date Received
    April 26, 2019
    Date of Event
    April 16, 2019
    Report Date
    May 22, 2019
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE AFFECTED FLOWMETER WAS PROVIDED FOR INVESTIGATION AND WAS VISUALLY INSPECTED. AN OBVIOUS CRACK AT THE THREAD WAS FOUND. THE PRESSURE DOME OF THE FLOWMETER IS MADE FROM CLEAR POLYCARBONATE TO ALLOW OBSERVATION OF THE INNER FLOW SCALE. THIS TYPE OF PLASTICS IS KNOWN TO BE SUSCEPTIBLE TO ALCOHOLS AND OTHER ORGANIC SUBSTANCES. THE PARTICULAR FLOW METER WAS IN OPERATION FOR APPROX. 10 YEARS AND HAS BEEN REPROCESSED WITH A FORMULATION CONTAINING ALCOHOL. THE IFU CONTAINS A CORRESPONDING WARNING: "RISK OF STRESS CRACKING: DO NOT USE DISINFECTANTS OR CLEANING AGENTS CONTAINING ALCOHOL." FURTHERMORE, THERE ARE RELATED WARNINGS THAT THE PARTS HAVE TO BE INSPECTED FOR MECHANICAL INTEGRITY PRIOR TO EACH USE PARTICULARLY FOR CRACKS IN THE PRESSURE DOME. IT IS ALSO DESCRIBED AS A WARNING THAT ONCE A YEAR THE DEPRESSURIZED PRESSURE DOME HAS TO BE UNSCREWED AND THE THREAD TO BE CHECKED BY SKILLED PERSONNEL FOR IRREGULARITIES AND CRACKS. FINALLY IT CAN BE CONCLUDED THAT REPROCESSING OVER A LONG PERIOD OF TIME WITH A SUBSTANCE CONTAINING ALCOHOL HAS CAUSED THE REPORTED EVENT. TO PREVENT FURTHER INSTANCES OF THIS KIND DISINFECTION AGENTS RECOMMENDED BY DRÄGER HAVE TO BE USED AND ALL OTHER FLOWMETERS AT THE HOSPITAL HAVE TO BE CHECKED FOR CRACKS AND HAVE TO BE EXCHANGED IF NECESSARY.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL-REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL ON-GOING. RESULTS WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRESSURE DOME OF A FLOW CONTROL TUBE EXPLODED AND THAT THE GLASS FLOW TUBE COVER SHOT AGAINST THE CEILING. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347824 FLOWMETER FLOWMETER-GAS BXY DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1