BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LSRFORTESSA X-20 SO

    MDR report key: 11620296 · Received April 6, 2021

    Report

    Report Number
    2916837-2021-00152
    Event Type
    Malfunction
    Date Received
    April 6, 2021
    Date of Event
    March 11, 2021
    Report Date
    June 9, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR#2916837-2021-00152 IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LSRFORTESSA X-20 SO BIOHAZARDOUS WASTE LEAKED OUTSIDE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: - ISSUE WASTE LEAKAGE FROM FACS FLOW SUPPLY SYSTEM. WAS THE LEAK LIQUID OR AIR? LIQUID WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD LSRFORTESSA X-20 SO BIOHAZARDOUS WASTE LEAKED OUTSIDE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ISSUE WASTE LEAKAGE FROM FACS FLOW SUPPLY SYSTEM. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    514954 BD LSRFORTESSA X-20 SO NA GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1