BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVERSE

    MDR report key: 11165960 · Received January 13, 2021

    Report

    Report Number
    2916837-2021-00019
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 22, 2020
    Report Date
    September 10, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD FACSVERSE 2L 6C SYSTEM WITH ACC KIT, PART # 651154 AND SERIAL #(B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT ON A BIOHAZARD LEAKAGE FROM THE SIT NOT CONTAINED WITHIN THE INSTRUMENT. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 22DEC2019 TO DATE 22DEC2020. ¿ COMPLAINT TREND: THERE ARE 9 COMPLAINTS RELATED TO A LEAKAGE FROM THE SIT NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 22DEC2019 TO DATE 22DEC2020. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #651154 SERIAL # (B)(6), FILE #651154-651154-Z6511540271-100153486-14, 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 BIOHAZARD LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOG IN THE V8 VALVE TUBING. THE CUSTOMER HAD REPORTED A LEAKAGE OF FLUID FROM THE SIT, BUT QUICKLY FOUND THAT IT WAS DUE TO AN ACCUMULATION OF CRYSTALS CLOGGING THE V8 TUBING. THE CUSTOMER ADJUSTED THE TUBING AND REPORTED THAT THE ISSUE HAD BEEN RESOLVED AND THE INSTRUMENT WAS WORKING AS INTENDED. NO PARTS WERE REQUESTED FOR EVALUATION SINCE NO PARTS WERE REPLACED, AND NO WORK ORDER HAD BEEN CREATED DUE TO THE CUSTOMER QUICKLY RESOLVING THE ISSUE. ALTHOUGH THE LEAKAGE OF BIOHAZARDOUS MATERIAL CAN CAUSE HARM TO THE CUSTOMER FROM EXPOSURE TO SAMPLES AND CHEMICALS, THE CUSTOMER WAS NOT HARMED IN ANY WAY AS THEY HAD NOT COME IN CONTACT WITH THE LEAKAGE. ADDITIONALLY, THE LEAK WAS NOT UNDER PRESSURE AND DID NOT SPRAY, AND THUS DID NOT SIGNIFICANTLY INCREASE THE RISK OF EXPOSURE. THIS INSTRUMENT WAS BEING USED FOR RESEARCH PURPOSES, NOT CLINICAL TREATMENT, AND SO THIS INCIDENT DID NOT AFFECT OR DELAY THE DIAGNOSIS OF A PATIENT. PROPER SCHEDULED CLEANING AND OTHER MAINTENANCE CAN HELP IN REDUCING THE POSSIBILITY OF CLOGS WITHIN THE V8 LINE, AND INSTRUCTIONS CAN BE FOUND IN CHAPTER 9 OF THE BD FACSVERSE¿ CLINICAL SYSTEM INSTRUCTIONS FOR USE (#23-11463-00 REV. 1/VERS. A). THE SAFETY RISK IS MODERATE, S3, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: N/A, CASE # 01220226 INSTALL DATE: 02OCT2014 DEFECTIVE PART NUMBER: N/A CASE COMMENTS: O SUBJECT / REPORTED: LIQUID LEAKS FROM SIT O [PHENOMENON] LEAKAGE FROM SIT O [CORRESPONDENCE] CUSTOMER CONFIRMS V8 VALVE TUBE. THE TUBE WAS SALTED OUT AND CLOGGED, SO REMOVE IT TO CHECK OPERATION AND IMPROVE THE SYMPTOMS ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THERE WERE NO PARTS REPLACED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 651155RA, REV. 11/VERS. B, LIBERTY RUO 1.0 RESEARCH SYSTEMS (FACSVERSE) RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO O HAZARD ID: 2.1.8B O HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. O CAUSE: BACKDRIP FROM INJECTION PORT. O HARMFUL EFFECTS: HARM TO OPERATOR. (EXPOSURE TO STAINED SAMPLE) O RISK CONTROLS: SIT FLUSH DESIGN TO CAPTURE BACK DRIPS. LIB-FLD-292 LIB-FLD-312, LIB-FLD-313, PROVIDE INSTRUCTION AND UNIVERSAL PRECAUTIONS. O IMP. VERIF.: SIT BACK FLOW CONTROL PROTOCOL LSV-1008-DP, SAMPLE CARRYOVER: SV-1013-DP, SLG: BIOLOGICAL SAFETY SECTION O EFF. VERIF.: SIT BACK FLOW CONTROL LSV-1008-TR, SAMPLE CARRYOVER: SV-1013-DR O PROBABILITY: 1 O SEVERITY: 1 O RISK INDEX: 1 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE O HAZARD ID: 2.1.9B O HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. O CAUSE: BACKDRIP FROM INJECTION PORT. O HARMFUL EFFECTS: DEGRADED INSTRUMENT PERFORMANCE (SENSORS, MOVING PARTS) REQUIRING FSE VISIT TO REPAIR DAMAGES. O RISK CONTROLS: SIT FLUSH DESIGN TO CAPTURE BACK DRIPS. LIB-FLD-292 LIB-FLD-312, LIB-FLD-313 PROPER SHIELDING (SKINS, UAL SPLASH GUARD) OF CRITICAL COMPONENTS, SURFACES. O IMP. VERIF.: SIT BACK FLOW CONTROL PROTOCOL LSV-1008-DP, SAMPLE CARRYOVER: SV-1013-DP, FLUIDIC MANAGEMENT LSVN1034-DP, CHEMICAL COMPATIBILITY OF METALS: LSVN1027-TP, RUO INSTRUMENT SKINS COVER KIT# 650669 AND IVD INSTRUMENT SKINS COVER KIT# 650670 O EFF. VERIF.: SIT BACK FLOW CONTROL LSV-1008-TR, SAMPLE CARRYOVER: SV-1013-DR, FLUIDIC MANAGEMENT: LSVN1034-DR, CHEMICAL COMPATIBILITY OF METALS: LSVN1027-TR O PROBABILITY: 1 O SEVERITY: 3 O RISK INDEX: 3 O RESIDUAL RISK EVALUATION: A O NEW HAZARDS: NONE MITIGATION(S) SUFFICIENT ¿YES ¿NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOGGED V8 LINE. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOGGED V8 LINE. THE CUSTOMER HAD REPORTED THE LEAKAGE AND DISCOVERED THAT IT WAS DUE TO A CLOG IN THE V8 VALVE TUBING BEFORE A WORK ORDER HAD TO BE CREATED. THE CUSTOMER CONFIRMED THAT THE INSTRUMENT FUNCTIONING AND NO LONGER LEAKED AFTER REMOVING THE CLOG FROM THE TUBING. NO ONE WAS HARMED OR¿INJURED¿DUE TO THE INCIDENT, AND SINCE THE INSTRUMENT WAS NOT BEING USED FOR CLINICAL TREATMENT, NO PATIENTS WERE AFFECTED. THE SAFETY RISK IS MODERATE, S3, AND THERE WAS AN IMPACT TO CUSTOMER HEALTH OR SAFETY. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OF BIOHAZARD WAS NOT CONTAINED WITHIN INSTRUMENT WHILE USING THE BD FACSVERSE¿. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM SIT CUSTOMER CONFIRMS V8 VALVE TUBE THE TUBE WAS SALTED OUT AND CLOGGED, SO REMOVE IT TO CHECK THE OPERATION AND IMPROVE THE SYMPTOMS. LIQUID LEAKS FROM SIT SAFETY QUESTIONS: WAS THE LEAK FLUID OR AIR? FLUID WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO WHAT WAS THE FLUID THAT LEAKED? BIO-HAZARD DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE NUMBER: (B)(4). INITIAL REPORTER FACILITY NAME: (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OF BIOHAZARD WAS NOT CONTAINED WITHIN INSTRUMENT WHILE USING THE BD FACSVERSE". THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE FROM SIT. CUSTOMER CONFIRMS V8 VALVE TUBE THE TUBE WAS SALTED OUT AND CLOGGED, SO REMOVE IT TO CHECK THE OPERATION AND IMPROVE THE SYMPTOMS. LIQUID LEAKS FROM SIT. SAFETY QUESTIONS: WAS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIO-HAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64753 BD FACSVERSE NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1