BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FACSVERSE

    MDR report key: 11681970 · Received April 16, 2021

    Report

    Report Number
    2916837-2021-00183
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 25, 2021
    Report Date
    September 28, 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 3L 8C SYSTEM WITH ACC KIT, PART # 651155, SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING A LEAKAGE OF BIOHAZARD 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 25MAR2020 TO 25MAR2021. ¿ COMPLAINT TREND: THERE ARE 16 COMPLAINTS RELATED TO THE INSTRUMENT LEAKAGE BIOHAZARD FROM THE SIT NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 25MAR2020 TO 25MAR2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 663029 SERIAL # (B)(6), FILE # (B)(4), 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 LEAK WAS DUE TO A WORN PINCH VALVE TUBING. THE PINCH VALVE¿S DEFAULT STATE IS PINCHED SHUT, SO IF AN INSTRUMENT IS UNUSED FOR A PROLONGED AMOUNT OF TIME THIS TUBING WILL BE WORN, CLOSED SHUT OR NOT FULLY OPEN AND WILL HAVE TO EITHER BE EXERCISED/MASSAGED AND RECONNECTED OR REPLACED ENTIRELY.BLOCKAGE OF THIS TUBE CAN COMMONLY CAUSE WEAKENED ASPIRATION OF THE SIT AND LEAD TO DRIPPING. THE TSR (TECHNICAL SERVICE REPRESENTATIVE) RESPONDING TO THE CUSTOMER COMPLAINT EXPLAINED THAT THE PINCH VALVE WAS LIKELY CRUSHED, AND THE CUSTOMER WAS ABLE TO IDENTIFY AND FIX THE TUBING. NO PARTS WERE REQUESTED FOR EVALUATION AS TUBING IS NOT RETURNABLE AND WAS DISCARDED. AFTER THE REPAIR THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS PERFORMING AS EXPECTED WITH NO FURTHER LEAKS. 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 FLUIDICS SYSTEM, 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 LIMITED, S2, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: N/A, CASE # (B)(4). INSTALL DATE: 18OCT2018. DEFECTIVE PART NUMBER: N/A. CASE COMMENTS: (3/25/21 2:00AM). [PHENOMENON] DURING SIT FLUSH, LIQUID DRIPS FROM SIT. I REPAIRED IT LAST MONTH (CORRECTLY THIS MONTH), BUT THE SAME PHENOMENON IS OCCURRING. [CORRESPONDENCE] I CALLED, BUT NO ONE WAS ABLE TO ANSWER. I¿LL CALL YOU AGAIN TOMORROW. (3/25/21 6:17PM). [CORRESPONDENCE] THE TUBE BITING THE PINCH VALVE WAS CRUSHED. THE USER RESHAPED THE TUBE AND BIT THE TUBE INTO THE PINCH VALVE AGAIN. 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, 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 OR NO. HAZARD ID: 2.1.8B. HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. CAUSE: BACKDRIP FROM INJECTION PORT. HARMFUL EFFECTS: HARM TO OPERATOR. (EXPOSURE¿TO STAINED SAMPLE) RISK CONTROLS: SIT FLUSH DESIGN TO CAPTURE BACK DRIPS. LIB-FLD-292, LIB-FLD-312, LIB-FLD-313, PROVIDE INSTRUCTION AND UNIVERSAL PRECAUTIONS. IMP. VERIF.: SIT BACK FLOW CONTROL PROTOCOL LSV-1008-DP, SAMPLE CARRYOVER: SV-1013-DP, SLG: BIOLOGICAL SAFETY SECTION EFF. VERIF.: SIT BACK FLOW CONTROL LSV-1008-TR, SAMPLE CARRYOVER: SV-1013-DR¿ PROBABILITY: 1. SEVERITY: 1. RISK INDEX 1. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. HAZARD ID: 3.1.62B. HAZARD: INSTRUMENT TEMPORARILY INOPERABLE. SOURCE: SIT FMEA. CAUSE: SAMPLE LINE ID COLLAPSES PREVENTING SAMPLE DELIVERY. TUBING BECOMES WORN/DAMAGED DURING ¿STINGER¿ OPERATION. LOW EVENT RATE. HARMFUL EFFECTS: 1.) DELAY IN DIAGNOSIS. 2.) TUBING MUST BE REPLACED. 3.) CUSTOMER ANNOYANCE. RISK CONTROLS: INCREASE IN SERVICE LOOP OF PEEKSIL TUBE SO THAT IT DOES NOT WEAR AND KINK AT THE CONNECTION POINTS. RELIABILITY TEST TO PROVIDE ESTIMATE LIFE OF PEEKSIL TUBE AND RECOMMENDED REPLACEMENT SCHEDULE. RELIABILITY SIT PROTOCOL. IMP. VERIF.: RELIABILITY LIFE TESTING COMPLETED VIA PROTOCOL. TESTING SHOWED THAT THERE IS NO SIGNIFICANT WEAR TO THE PEEKSKILL TUBING. PROTOCOL NAME: LIBERTY SIT RELIABILITY TEST PROTOCOL. EFF. VERIF.: PUBLISHED RELIABILITY REPORT WHICH DEMONSTRATED AT LEAST 1.5 YEARS OF LIFE WITH NO SIGNIFICANT DAMAGE OR KINKS. REPORT NAME: LIBERTY SIT RELIABILITY REPORT. PROBABILITY: 2. SEVERITY: 2. RISK INDEX: 4. RESIDUAL RISK EVALUATION: A. NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT :YES OR NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF A BIOHAZARD LEAK NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN PINCH VALVE TUBING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF A BIOHAZARD LEAK NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A WORN PINCH VALVE TUBING. A TSR WAS ABLE TO HELP THE CUSTOMER IDENTIFY THE ISSUE, AND THE CUSTOMER WAS ABLE TO REPAIR THE LEAKAGE BY ADJUSTING THE PINCH VALVE TUBING. AFTER THE REPAIR, THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS FUNCTIONING AS EXPECTED. 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 LIMITED, S2, AND THERE WAS NO IMPACT TO THE CUSTOMER HEALTH OR SAFETY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD FACSVERSE¿ BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER/PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DRIPPING FROM SIT DURING SIT FLASH SINCE THE TUBE BITTEN BY THE PINCH VALVE WAS CRUSHED, THE USER RESTORED THE SHAPE OF THE TUBE AND HAD THE PINCH VALVE BITE THE TUBE AGAIN ACCORDING TO BDJ'S ADVICE ON THE PHONE. THE CUSTOMER CURRENTLY USES THE INSTRUMENT AS USUAL. NO MORE ACTION IS PLANNED AS OF NOW. 1. WAS THE LEAK FLUID OR AIR? FLUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD FACSVERSE¿ BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER/PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DRIPPING FROM SIT DURING SIT FLASH SINCE THE TUBE BITTEN BY THE PINCH VALVE WAS CRUSHED, THE USER RESTORED THE SHAPE OF THE TUBE AND HAD THE PINCH VALVE BITE THE TUBE AGAIN ACCORDING TO BDJ'S ADVICE ON THE PHONE. THE CUSTOMER CURRENTLY USES THE INSTRUMENT AS USUAL. NO MORE ACTION IS PLANNED AS OF NOW. 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? BIOHAZARD. 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
    579986 BD FACSVERSE NA OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES NA

    Patients

    Seq Age Sex Outcome Treatment
    1