BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART

    MDR report key: 17971962 · Received October 20, 2023

    Report

    Report Number
    2916837-2023-00202
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    October 2, 2023
    Report Date
    July 11, 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
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - (B)(4). G.1 - MANUFACTURING SITE CONTACT - (B)(4). G.1 - REPORTING OFFICE- BECTON DICKINSON AND COMPANY BD BIOSCIENCES. H6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE WASTE SHOWING AS FULL EVEN THOUGH IT WAS EMPTY WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DEVICE HISTORY RECORD REVIEW, AND RISK ANALYSIS. THE CAUSE OF THE WASTE TANK ERROR REPORTED IN THE COMPLAINT WAS NOT IDENTIFIED BECAUSE THE CUSTOMER DID NOT RESPOND BACK TO THE FSE. SUBSEQUENT VISITS BY THE FIELD SERVICE ENGINEER RESULTED IN SUCCESSFUL PREVENTIVE MAINTENANCE AND THE INSTRUMENT IS RUNNING 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART ERROR MESSAGE FOR WASTE WAS RECEIVED AND BYPASSED. THERE WAS NO REPORT OF ANY PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT WASTE IS SHOWING AS FULL EVEN THOUGH IT IS EMPTY 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART ERROR MESSAGE FOR WASTE WAS RECEIVED AND BYPASSED. THERE WAS NO REPORT OF ANY PATIENT OR USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT WASTE IS SHOWING AS FULL EVEN THOUGH IT IS EMPTY 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241767 BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART COUNTER, DIFFERENTIAL CELL OYE BECTON DICKINSON AND COMPANY BD BIOSCIENCES NA 00382903389629

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown