BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO¿ II

    MDR report key: 18016548 · Received October 26, 2023

    Report

    Report Number
    2916837-2023-00207
    Event Type
    Malfunction
    Date Received
    October 26, 2023
    Date of Event
    October 7, 2023
    Report Date
    June 26, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    UDI-DI
    00382903389629
    PMA / PMN Number
    K141468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - BECTON DICKINSON AND COMPANY BD BIOSCIENCES SAN JOSE CA, 95131. G.1 - REPORTING OFFICE CONTACT - (B)(4). G.1 - MANUFACTURING SITE CONTACT - (B)(4). H.6 - IMDRF ANNEX F CODE- F26. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF TUBE NOT PRESSURIZED WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE DUE TO DAMAGE TO FITTINGS OVER TIME IN THE BAL SEAL ASSEMBLY. FSE COMPLETED THE REPAIR AND THE INSTRUMENT IS FUNCTIONING AS EXPECTED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART TUBE COULD NOT PRESSURIZE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED ERROR TUBE COULD NOT PRESSURIZE. CHECK WET CART PRESSURE IS OK AT 65, ERROR OCCUR WHILE USING LOADER. LIFTER ROD IS CLEAN, CUSTOMER CHECK DRAWER IS PROPERLY LOCKED INTO POSITION. THERE WERE NO BROKEN WIRES IN THE CABLE BEAM FROM THE LOADER. CUSTOMER ALSO TRIED REPLACE BAL SEAL, NO DAMAGE FOUND ON THE SIT AREA AROUND BAL SEAL/NUT RETAINER. ERROR STILL PERSISTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART TUBE COULD NOT PRESSURIZE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED ERROR TUBE COULD NOT PRESSURIZE. CHECK WET CART PRESSURE IS OK AT 65, ERROR OCCUR WHILE USING LOADER. LIFTER ROD IS CLEAN, CUSTOMER CHECK DRAWER IS PROPERLY LOCKED INTO POSITION. THERE WERE NO BROKEN WIRES IN THE CABLE BEAM FROM THE LOADER. CUSTOMER ALSO TRIED REPLACE BAL SEAL, NO DAMAGE FOUND ON THE SIT AREA AROUND BAL SEAL/NUT RETAINER. ERROR STILL PERSISTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691044 BD FACSCANTO¿ II COUNTER, DIFFERENTIAL CELL OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES 00382903389629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown