BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSYMPHONY

    MDR report key: 10994441 · Received December 12, 2020

    Report

    Report Number
    2916837-2020-00301
    Event Type
    Malfunction
    Date Received
    December 12, 2020
    Date of Event
    November 16, 2020
    Report Date
    June 8, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    GKZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW MFR# 2916837-2020-00301 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 THAT BD FACSYMPHONY¿ LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ISSUE 1: SLOW FLOW RATE MADE THE HYDROPHOBIC FILTER GET WET (2067804) ISSUE 2: DCM PUMP DOES NOT PULL FLUID OFF THE SIP (B)(6). MATERIAL NO: 660964 SERIAL NO: (B)(6). IT WAS REPORTED THAT THERE IS A SLOW FLOW RATE MADE THE HYDROPHOBIC FILTER GOT WET. ALSO, THE DCM PUMP DOES NOT PULL FLUID OFF THE SIP. "WAS THERE A FLUIDIC LEAK OR SPILL? YES. 1.WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 2. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. 3. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. 4. WHAT WAS THE FLUID THAT LEAKED/SPILLED? SHEATH. 5. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE LINE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD FACSYMPHONY¿ LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ISSUE 1: SLOW FLOW RATE MADE THE HYDROPHOBIC FILTER GET WET (2067804) ISSUE 2: DCM PUMP DOES NOT PULL FLUID OFF THE SIP (2071713) MATERIAL NO: 660964 SERIAL #: (B)(4). IT WAS REPORTED THAT THERE IS A SLOW FLOW RATE MADE THE HYDROPHOBIC FILTER GOT WET. ALSO, THE DCM PUMP DOES NOT PULL FLUID OFF THE SIP. "WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? SHEATH. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459586 BD FACSYMPHONY DIFFERENTIAL CELL COUNTER GKZ BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1