BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FACSARIA¿ FUSION 6B/3R/3V ACDU W/HOOD

    MDR report key: 9774946 · Received March 2, 2020

    Report

    Report Number
    2916837-2020-00001
    Event Type
    Injury
    Date Received
    March 2, 2020
    Date of Event
    February 7, 2020
    Report Date
    February 13, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    RUO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). MEDICAL DEVICE EXPIRATION DATE: N/A. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART 656700G5 AND SERIAL (B)(4). PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT ON EXPOSURE TO ETHANOL ON EYES BY THE RELEASE OF PRESSURIZED ETHANOL DURING THE PURGING OF THE AIR BUBBLES FROM THE INSTRUMENT'S ETHANOL TANK FILTER. MANUFACTURING DEFECT TREND: THERE ARE NO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS) RELATED QN(S) NUMBER: N/A. SEARCH QUERY: SAP TCODE QM15: NOTIFICATION DATE (B)(6) 2019 TO DATE (B)(6) 2020; MATERIAL= 656700G5 OR 661744. COMPLAINT TREND: THERE ARE 62 COMPLAINTS RELATED TO THE REPORTED COMPLAINTS. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS). COMPLAINT TREND RELATED TO THIS INCIDENT ARE BEING TRENDED AND MONITORED AS PART OF CAPA (B)(4). RELATED COMPLAINT(S) NUMBER: REFER TO COMPLAINT REPORT REQUEST FORM - (NOTE: RELATED COMPLAINT NUMBERS WITHIN THE DATE RANGE ARE HIGHLIGHTED IN YELLOW). MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF DHR PART 656700G5 AND SERIAL (B)(4). WAS PERFORMED. THE INSTRUMENT WAS MANUFACTURED ON 25-APR-2019. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. REFERENCE: FROM DOCUMENTUM PRODUCT HISTORY LIBRARY: FILE NAME: (B)(4). SERVICE RECORD REVIEW: INSTRUMENT WAS INSTALLED AT CUSTOMER SITE ON (B)(6) 2019. REVIEW OF RELATED SERVICEMAX CASE # 00944367; WORK ORDER - WO-01328891. DEFECTIVE PART NUMBER: NO DEFECTIVE COMPONENTS WORK ORDER NOTES: SUBJECT / REPORTED: (B)(6) - FACSARIA FUSION - ETHANOL/SHEATH FILTER SAFETY ISSUE. PROBLEM DESCRIPTION: THE CUSTOMER WAS INJURED BY THE RELEASE OF PRESSURIZED ETHANOL DURING THE PURGING OF THE AIR BUBBLES FROM THE ETHANOL TANK'S FILTER. CAUSE: THE INSTRUMENT IS FUNCTIONING WITHIN SPECIFICATION, NO FIX NEEDED. WORK PERFORMED: THE INSTRUMENT IS FUNCTIONING WITHIN SPECIFICATION, NO FIX. NEEDED. SOLUTION: THE INSTRUMENT IS FUNCTIONING WITHIN SPECIFICATION, NO FIX NEEDED. RETURNED SAMPLE EVALUATION: NO SAMPLES REQUESTED TO BE RETURNED SINCE THERE WERE NO REPORTED DAMAGED COMPONENTS WHICH REQUIRES REPLACEMENT PER SERVICE REPORT. RISK ANALYSIS: RISK MANAGEMENT FILE PART 100286RA, REVISION 02 WAS REVIEWED. A REVIEW OF FACSARIA PRODUCT FAMILY RISK ANALYSIS FACSARIA FUSION RISK ANALYSIS 100286RA VERSION F, WAS PERFORMED. CHEMICAL HAZARD FOR CHEMICAL SPILLS IS DOCUMENTED UNDER ID 2.2.2; HOWEVER, SPECIFIC HAZARD ASSOCIATED TO ETHANOL /CHEMICAL SPRAY TO USER OR TO SURROUNDING IS NOT CURRENTLY CAPTURED. UPDATE TO THE RISK ANALYSIS DOCUMENT SHALL BE PERFORMED AS PART OF CAPA (B)(4). A PRELIMINARY RISK ASSESSMENT WAS PERFORMED ON ETHANOL SPRAY UNDER CAPA (B)(4). NOTE: RISK IS DENOTED BY A RISK INDEX (RI), WHERE RI = SEVERITY (S) X PROBABILITY (P) SEVERITY ¿ IMPACT TO CUSTOMER (HAZARDOUS SITUATION): ETHANOL SPRAY ONTO USER OR SURROUNDING PERSONNEL. SEVERITY BASED ON RISK TABLE = 1 POTENTIAL FAILURE ¿ USER OR SURROUNDING PERSONNEL COME IN SKIN CONTACT WITH ETHANOL FLUID.. USER DID NOT AIM THE ETHANOL AT CONTAINER DURING FILTER PURGING OR USER DID NOT PERFORM TANK DEPRESSURIZING STEP DURING FILTER CHANGE. PROBABILITY LEADING TO INJURY = 4 (PROBABLE) RISK LEVEL = LOW. SEVERITY ¿ IMPACT TO CUSTOMER (HAZARDOUS SITUATION): ETHANOL SPRAY ONTO SURROUNDING MACHINERY. SEVERITY BASED ON RISK TABLE = 2. POTENTIAL FAILURE ¿ TRIPPING HAZARD. USER DID NOT WIPE UP ANY EXCESS FLUID THAT MIGHT HAVE DRIPPED OR SPRAYED ON THE FLOOR. PROBABILITY LEADING TO INJURY = 1 (IMPROBABLE) RISK LEVEL = LOW. INVESTIGATION RESULT / ANALYSIS: ON (B)(6) 2020, BD WAS MADE AWARE OF AN INCIDENT WHERE A CUSTOMER WAS INJURED BY THE RELEASE OF PRESSURIZED ETHANOL DURING THE PURGING OF THE AIR BUBBLES FROM THE ETHANOL TANK'S FILTER ON A FACSARIA FUSION INSTRUMENT. THE USER WAS CONFIRMED TO BE WEARING PPE (PERSONAL PROTECTIVE EQUIPMENT) AND GLASSES (VISION CORRECTING GLASSES, NOT A PROTECTIVE EYEWEAR); THE ETHANOL SPRAYED UNDER THE GLASSES INTO THE CUSTOMER'S EYES. THE CUSTOMER NEEDED MEDICAL INTERVENTION AFTER EYE EXPOSURE TO ETHANOL. UPDATE ON THE CUSTOMER'S STATUS ON (B)(6) 2020 INDICATED THAT THE CUSTOMER IS IN A HEALTHY CONDITION WITH NO LASTING DAMAGE AS CONFIRMED BY THE CUSTOMER'S OPHTHALMOLOGIST. CUSTOMER HAS SINCE GONE BACK TO WORK. FROM THE INTERVIEW, LACK OF PROPER EYEWEAR PPE MAY HAVE ATTRIBUTED TO THE EXPOSURE OF THE USER TO THE ETHANOL SPRAY. OVERALL,THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, DHR REVIEW, ROOT CAUSE AND RISK ANALYSIS, THE REPORTED COMPLAINT WAS CONFIRMED. FLUID SPRAY OUT FROM FILTERS (PN 661744 FILTER QUICK CONN FEM FEM 0.2UM PPL) IS A KNOWN ISSUE AND CORRECTIVE ACTIONS ARE CURRENTLY BEING ADDRESSED UNDER CAPA (B)(4). THIS IS CONSIDERED AS A SAFETY CONCERN AND CUSTOMER WAS NOTIFIED OF THIS ISSUE THROUGH A CUSTOMER NOTIFICATION LETTER AND DIRECTIONS FOR USE FOR THE FILTER IN (B)(6) 2018 VIA THE BDB-19-1393 ADVISORY WHICH ARE TO THIS COMPLAINT FOR REFERENCE. WITHIN THE CUSTOMER LETTER, IT STATES THAT: ¿BD HAS RECENTLY CONFIRMED A POTENTIAL FOR ETHANOL OR SHEATH FLUID TO SPRAY FROM THE SHEATH/ETHANOL FILTER, PART NUMBER 661744, DURING THE DAILY SHUTDOWN, THE WEEKLY FILTER PURGE AND/OR THE 6-MONTH FILTER CHANGE MAINTENANCE ACTIVITIES OF THE BD FACSARIA¿ INSTRUMENTS LISTED ABOVE. THE FLUID SPRAY MAY OCCUR IF THE FILTER HAS BEEN DAMAGED FROM IMPACT WITH A HARD SURFACE DURING BUBBLE REMOVAL, IF THE CONNECTOR IS NOT FULLY ENGAGED IN THE FITTING OR IF THE FILTER VENT CAP COMES OFF.¿ ON THE DIRECTION FOR USE (BD PN 23-21212-00) UNDER WARNINGS, IT NOTIFIES USER THAT "THE VENT CAP WILL COME OFF AFTER A ¼ OF A TURN. THE FILTER IS PRESSURIZED, SO AIM THE FILTER AWAY FROM BODY OR INSTRUMENT AND INTO A SEPARATE CONTAINER BEFORE TURNING THE VENT CAP" AND TO " WEAR PROPER PERSONAL PROTECTION EQUIPMENT SUCH AS LAB COATS, SAFETY GLASSES OR SAFETY FACE GUARD, AND GLOVES BEFORE HANDLING OF FILTERS." WITHIN THE SAFETY AND LIMITATIONS GUIDE (REF: 23-14817-00, FACSARIA FUSION), WHICH WAS INITIALLY PROVIDED TO INSTRUMENT OWNERS AS PART OF THE INSTRUMENT DURING INSTALLATION, USERS ARE INSTRUCTED TO WEAR SUITABLE PROTECTIVE CLOTHING, EYEWEAR, AND GLOVES AS PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN OPERATING THE INSTRUMENT PER TO MINIMIZE EXPOSURE OF CHEMICAL AND/OR BIOHAZARDS. ROOT CAUSE: THE COMPLAINT INVOLVES FLUID SPRAY OUT FROM FILTERS (PN 661744 FILTER QUICK CONN FEM FEM 0.2UM PPL) WHICH IS A KNOWN ISSUE CURRENTLY BEING ADDRESSED UNDER CAPA (B)(4). PER CAPA (B)(4), ROOT CAUSE WAS DETERMINED TO BE DESIGN RELATED SUMMARIZED IN THE FOLLOWING: BLEEDER VALVE: CURRENT VALVE DESIGN (LUER TAPER FITTING) MAY CAUSE THE USER BE SPRAYED BY THE FLUID (SHEATH OR ETHANOL). CRACK CAPSULE SHELL: USERS ARE TAPPING/BANGING THE FILTER AGAINST HARD OBJECTS IN AN EFFORT TO DISLODGE BUBBLES FROM WITHIN THE FILTER ASSEMBLY. CONNECTOR: FLUID SPRAYS OUT FROM THE QUICK-DISCONNECT FITTING WHEN IT IS NOT FULLY ENGAGE ONTO THE MATING CONNECTOR. EARLY LIFE FAILURE: CURRENT FILTER HAS A SHORTER LIFE THAN PREVIOUS PALL FILTER DUE TO SMALLER FILTRATION AREA. CONCLUSION: INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, DHR REVIEW, ROOT CAUSE AND RISK ANALYSIS, THE REPORTED COMPLAINT WAS CONFIRMED. FLUID SPRAY OUT FROM FILTERS (PN 661744 FILTER QUICK CONN FEM FEM 0.2UM PPL) IS A KNOWN ISSUE AND CORRECTIVE ACTIONS ARE CURRENTLY BEING ADDRESSED UNDER CAPA (B)(4). THIS IS CONSIDERED AS A SAFETY CONCERN WHICH WAS PREVIOUSLY NOTIFIED TO THE CUSTOMER THROUGH A CUSTOMER NOTIFICATION LETTER AND DIRECTIONS FOR USE FOR THE FILTER IN (B)(6) 2018 VIA THE BDB-19-1393 ADVISORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TECHNICIAN HAD ETHANOL SPRAYED INTO THEIR EYES WHILE OPERATING FACSARIA¿ FUSION 6B/3R/3V ACDU W/HOOD (RUO). THE FOLLOWING WAS PROVIDED IN THE INITIAL REPORT. CUSTOMER NEED MEDICAL INTERVENTION AFTER EYE BEING EXPOSED TO ETHANOL. THIS IS RELATED TO THE CAPA HANGING FOR THOSE FILTERS. THE CUSTOMER WAS INJURED BY THE RELEASE OF PRESSURIZED ETHANOL DURING THE PURGING OF THE AIR BUBBLES FROM THE ETHANOL TANK'S FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238090 FACSARIA¿ FUSION 6B/3R/3V ACDU W/HOOD FLOW CYTOMETER OYE BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention