BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 8460491 · Received March 28, 2019

    Report

    Report Number
    2916837-2019-00107
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    February 25, 2019
    Report Date
    April 16, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
    Product Code
    OYE
    PMA / PMN Number
    RUO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: RESULT OF DEVICE HISTORY RECORD (DHR) REVIEW: REVIEWED 656700G2-656700G2-P656700G20007-100679636-15. NO ISSUES RELATED TO THIS FAILURE MODE WERE IDENTIFIED. DEFECT TREND: QNS (ZM, ZE) RELATED TO THIS ISSUE IN SAP FROM 01/MAR/2018 TO 27/FEB/2019 = 0. INVESTIGATION RESULT / ANALYSIS: THE USER STATED THAT AT THE START OF THE EXPERIMENT (FACS SORTING) THEY WERE WEARING PROTECTIVE EQUIPMENT (FACE GUARD OR GOGGLES), HOWEVER AFTER COMPLETING THE EXPERIMENT THEY REMOVED THEIR PROTECTIVE EQUIPMENT. THE USER PERFORMED A FLUIDICS SHUTDOWN (PER BD FACSARIA FUSION USER¿S GUIDE 23-14816-01, REV 01, PAGE 208) ON THE INSTRUMENT WITHOUT WEARING PROTECTIVE EQUIPMENT. THE USER NOTICED THE OUTER SURFACE OF THE ETHANOL FILTER WAS WET WITH FLUID (THE FILTER CAP WAS LOOSE BECAUSE THE OUTSIDE OF THE FILTER WAS WET) WHILE CONNECTING THE SUPPLY LINE FROM THE SHEATH TANK TO THE 70% ETHANOL TANK. WHILE THE USER WAS HOLDING THE ETHANOL FILTER (WHICH WAS UNDER 70 PSI) IN HAND THE LOOSE BLEEDER CAP BECAME DISENGAGED, AND 70% ETHANOL WAS DISCHARGED OUT OF THE ETHANOL FILTER AND DRIPPED DOWN THE USER'S HEAD AND EYES. THE USER IMMEDIATELY PERFORMED EMERGENCY DECONTAMINATION STEPS BY RINSING THEIR HEAD AND EYES WITH WATER. THE USER RECEIVED TREATMENT FROM DR. (B)(6) OF THE DEPARTMENT OF INTERNAL MEDICINE, UNIVERSITY OF TOKYO IN THE NEXT ROOM. AN IMMEDIATE MEDICAL EXAMINATION WAS PERFORMED AT THE (B)(6) EYE CLINIC WHICH CONFIRMED THERE WAS NO EYE ABNORMALITY OR SCARRING. THE PURPOSE OF THE BLEEDER VALVE ON THE TOP OF THE FILTER IS TO PURGE THE AIR AND THE SHEATH FROM THE FILTER. EACH INSTRUMENT HAS TO PERFORM A MINIMUM WEEKLY PURGE. PER INSTRUCTIONS IN THE BD FACSARIA FUSION USER¿S GUIDE (23-14816-01, REV 01, PAGE 217), "PURGING THE FLUID FILTERS ONCE A WEEK, PURGE AIR FROM THE SHEATH FILTER BY OPENING THE BLEEDER VALVE ON THE TOP OF THE FILTER. THE SHEATH TANK IS PRESSURIZED, SO DO THIS CAREFULLY TO AVOID SPRAYING SHEATH FLUID ON ANY EQUIPMENT. 1. PLACE A SMALL CONTAINER UNDER THE BLEEDER VALVE TO CATCH ANY FLUID. 2. SLOWLY OPEN THE BLEEDER VALVE A SMALL AMOUNT AND LEAVE IT OPEN UNTIL FLUID SEEPS OUT THROUGH THE VALVE. 3. CLOSE THE VALVE. 4. WIPE UP ANY EXCESS FLUID THAT MIGHT HAVE DRIPPED INTO THE FLUIDICS DRAWER." THIS ACTION IS TO PREVENT THE FLUID FROM POURING OUT IN A RUSH STREAM. THIS FILTER BLEEDER VALVE CAP TAKES APPROXIMATELY 1 TURN TO ENGAGE AND DISENGAGE. IN ADDITION, PER BD FACSARIA FUSION SAFETY AND LIMITATIONS GUIDE (23-14817-00, REV 01, PAGE 23), USERS ARE INSTRUCTED TO ¿WEAR SUITABLE PROTECTIVE CLOTHING, EYEWEAR, AND GLOVES.¿ AS PERSONAL PROTECTIVE EQUIPMENT (PPE) SHOULD BE WORN WHEN OPERATING THE INSTRUMENT. ASSIGNABLE CAUSE: THE BLEEDER VALVE CAP WAS LOOSE, RESULTING IN THE CAP TO DISENGAGE AND CAUSE THE FLUID STREAM TO RUSH OUT. THE ROOT CAUSE WILL BE INVESTIGATED AS PART OF THE CORRECTIVE AND PREVENTATIVE ACTION (CAPA) INVESTIGATIONS, REFER TO CAPA 682450 FOR FURTHER ACTION FOR THIS ISSUE. RETURN GOODS AUTHORIZATION (RGA)/ RETURN MATERIAL AUTHORIZATION (RMA) RETURNED SAMPLE EVALUATION: NO REQUEST WAS MADE FOR THE ETHANOL FILTER TO BE RETURNED BECAUSE THE USER REINSTALLED THE CAP AND CONTINUED USING THE FILTER. CONCLUSION: THE BLEEDER VALVE CAP WAS LOOSE, RESULTING IN THE CAP TO DISENGAGE AND CAUSE THE FLUID STREAM TO RUSH OUT. THE ETHANOL FILTER CAP WAS LOOSE BECAUSE THE OUTSIDE OF THE FILTER WAS WET BEFORE THE CAP FLEW OFF. THE USER WAS WEARING PROTECTIVE EQUIPMENT DURING THE EXPERIMENT; HOWEVER, BEFORE CHANGING THE FLUID LINES THE USER REMOVED THE PROTECTIVE EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A FACSARIA¿ FUSION 6B/3R/3V ACDU W/HOOD (A RESEARCH USE ONLY, RUO, DEVICE) THE LAB TECHNICIAN ATTEMPTED TO CHANGE THE FLUID LINE FROM THE 70% ETHANOL TANK. THE LAB TECHNICIAN NOTED THAT THE OUTSIDE OF THE FILTER WAS WET. WHILE THE LAB TECHNICIAN WAS HOLDING THE FILTER, THE FILTER CAP CAME LOOSE AND FLUID FROM THE 70% ETHANOL FILTER SPRAYED INTO THE LAB TECHNICIAN'S FACE GETTING INTO THEIR EYES. THE LAB TECHNICIAN WASHED THEIR HEAD AND EYES WITH RUNNING WATER AND WIPED AWAY THE FLUID. THE LAB TECHNICIAN SOUGHT MEDICAL ATTENTION FORM A PHYSICIAN IN THE DEPARTMENT OF INTERNAL MEDICINE. THE PHYSICIAN GAVE THE LAB TECHNICIAN A MEDICAL EVALUATION AND ASSESSED THE CONDITION OF THEIR EYES. THE LAB TECHNICIAN RECEIVED FURTHER EXAMINATION AT THE HOSPITAL'S EYE CLINIC WHICH CONFIRMED THERE WAS NO ABNORMALITY OR SCARRING IN THE PATIENT'S EYES.

    Additional Manufacturer Narrative · 1

    THE FACSARIA¿ FUSION IS A PRODUCT INTENDED FOR RESEARCH USE ONLY AND THIS REPORT IS FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO SERIOUS INJURY. (B)(6). DEVICE EVALUATED BY MFR: 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 THAT WHILE USING A FACSARIA¿ FUSION 6B/3R/3V ACDU W/HOOD (A RESEARCH USE ONLY, RUO, DEVICE) THE LAB TECHNICIAN ATTEMPTED TO CHANGE THE FLUID LINE FROM THE 70% ETHANOL TANK. THE LAB TECHNICIAN NOTED THAT THE OUTSIDE OF THE FILTER WAS WET. WHILE THE LAB TECHNICIAN WAS HOLDING THE FILTER, THE FILTER CAP CAME LOOSE AND FLUID FROM THE 70% ETHANOL FILTER SPRAYED INTO THE LAB TECHNICIAN'S FACE GETTING INTO THEIR EYES. THE LAB TECHNICIAN WASHED THEIR HEAD AND EYES WITH RUNNING WATER AND WIPED AWAY THE FLUID. THE LAB TECHNICIAN SOUGHT MEDICAL ATTENTION FORM A PHYSICIAN IN THE DEPARTMENT OF INTERNAL MEDICINE. THE PHYSICIAN GAVE THE LAB TECHNICIAN A MEDICAL EVALUATION AND ASSESSED THE CONDITION OF THEIR EYES. THE LAB TECHNICIAN RECEIVED FURTHER EXAMINATION AT THE HOSPITAL'S EYE CLINIC WHICH CONFIRMED THERE WAS NO ABNORMALITY OR SCARRING IN THE PATIENT'S EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255930 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