BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVERSE¿

    MDR report key: 14577127 · Received June 2, 2022

    Report

    Report Number
    2916837-2022-00143
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    June 1, 2022
    Report Date
    September 28, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    K201814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE#: (B)(6). THE EVENT DESCRIBED OCCURRED ON AN RUO INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. 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

    INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACSVERSE 3L 8C SYSTEM WITH ACC KIT, PART # 651155, AND SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 01JUN2021 TO DATE 01JUN2022. COMPLAINT TREND: THERE ARE 2 COMPLAINTS RELATED TO A WASTE LEAKAGE DUE TO LOOSE COMPONENTS; PR# (B)(4) AND THIS ONE, 5290639. DATE RANGE FROM 01JUN2021 TO DATE 01JUN2022. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 651155 SERIAL # (B)(6), FILE # 651155-651155-Z6511550541-100951993-16, WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A LOOSE WASTE LIQUID BUCKET. THE CUSTOMER HAD INITIALLY REPORTED A FLUIDIC LEAKAGE OUTSIDE OF THE INSTRUMENT AND THAT THE WASTE TANK WAS EMPTY. AN FSE (FIELD SERVICE ENGINEER) WAS SENT ONSITE FOR THE REPAIR, AND PER (B)(4) IN TRACKWISE, THE FSE TIGHTENED THE WASTE LIQUID BUCKET AND CALIBRATED THE INSTRUMENT. AFTER THIS REPAIR, THE INSTRUMENT WAS FUNCTIONING AS EXPECTED AND WAS NO LONGER LEAKING. NO PARTS WERE REQUESTED FOR EVALUATION AS THERE WERE NO PARTS REPLACED. ALTHOUGH THERE WAS A LEAKAGE OF BIOHAZARDOUS FLUID OUTSIDE OF THE INSTRUMENT, THE CUSTOMER CONFIRMED THAT THEY DID NOT COME IN CONTACT WITH THE FLUID AND WERE NOT HARMED IN ANY WAY. ADDITIONALLY, THERE WAS NO SPRAY OF FLUID SO THERE WAS NO INCREASED RISK OF CONTACT. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 02475216, CASE # (B)(4). INSTALL DATE: 06FEB2017. DEFECTIVE PART NUMBER: N/A. WORK ORDER NOTES: SUBJECT / REPORTED: PI-651155-FACSVERSE-INSTRUMENT LEAK. PROBLEM DESCRIPTION: FACSVERSE - INSTRUMENT LEAKS THE INSTRUMENT IS LEAKING LIQUID, NOT SHEATH LIQUID, GUESS IT IS WASTE LIQUID, THE WASTE LIQUID TANK IS EMPTY, THE USER IS MORE ANXIOUS RESEARCH USE. WORK PERFORMED: CALIBRATION INSTRUMENT, PROBLEM SOLVING. CAUSE: CALIBRATION INSTRUMENT, PROBLEM SOLVING. SOLUTION: CALIBRATION INSTRUMENT, PROBLEM SOLVING. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO REPLACED PARTS. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 651155RA, REV. 11/VERS. B, RISK ANALYSIS LIBERTY WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES, NO. HAZARD ID: 2.1.12B. HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. CAUSE: WASTE OVERFLOW. HARMFUL EFFECTS: INJURY TO OPERATOR (INFECTION). RISK CONTROL(S): SYSTEM SHALL DETECT AND ALERT WHEN WASTE IS FULL. FOLLOW UNIVERSAL PRECAUTIONS INCLUDED IN USER DOCUMENTATION. IMPLEMENTATION VERIFICATION: SHEATH AND WASTE LEVEL ALERTS PROTOCOL 1009-DP. LIB-VER-10-02P. SLG: BIOLOGICAL SAFETY. EFFECTIVENESS VERIFICATION: SHEATH AND WASTE LEVEL ALERTS PROTOCOL 1009-DR. LIB-VER-10-02F. PROBABILITY: 1. SEVERITY: 1. RISK INDEX: 1. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT YES, NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A LOOSE WASTE LIQUID BUCKET. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A LOOSE WASTE LIQUID BUCKET. THE FSE CONFIRMED THE ISSUE, TIGHTENED THE WASTE LIQUID BUCKET, AND CALIBRATED THE INSTRUMENT. AFTER THE REPAIR, THE INSTRUMENT WAS FUNCTIONING AS EXPECTED WITH NO FURTHER LEAKAGES. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE LEAK. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. SUPPORTING DOCUMENT: N/A H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSVERSE¿ LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ""FACSVERSE - INSTRUMENT LEAKS THE INSTRUMENT IS LEAKING LIQUID, NOT SHEATH LIQUID, GUESS IT IS WASTE LIQUID, THE WASTE LIQUID TANK IS EMPTY, THE USER IS MORE ANXIOUS. RESEARCH USE. TASK ANSWER: 1WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.):LIQUID. 2WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.):NOT CONTAINED. 3WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4):NO. 4WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5):BIOHAZARD. 5DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6):BEFORE WASTE LINE. 7WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD FACSVERSE¿ LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ""FACSVERSE - INSTRUMENT LEAKS THE INSTRUMENT IS LEAKING LIQUID, NOT SHEATH LIQUID, GUESS IT IS WASTE LIQUID, THE WASTE LIQUID TANK IS EMPTY, THE USER IS MORE ANXIOUS RESEARCH USE. TASK ANSWER: 1WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.):LIQUID 2WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.):NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4):NO. 4WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5):BIOHAZARD. 5DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6):BEFORE WASTE LINE 7WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135020 BD FACSVERSE¿ NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown