BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS MEDICAL DEVICE EXPIRATION DATE: NA. 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

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVER FLOWING. CLEANED THE INLINE FILTER. HAS TRIED REMOVING THE CONNECTORS AND FLUSHING WITH A SYRINGE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CHECKED IF INLINE FILTER WAS CLEANED. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES EXPLAIN)? Y, WASH TOWER OVERFLOWED. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? YES. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y. ADDITIONALLY, ON 2020-8/13 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE FLUID WAS A COMBINATION OF WASTE, WATER AND SHEATH FLUID. THE FLUIDS WERE NOT CONTAINED IN THE SYSTEM. THE CUSTOMER WAS NOT INJURED OR HARMED AS A RESULT OF THE FLUID. THE FLUID WAS CLEANED AND DISINFECTED USING BLEACH SOLUTION.

Description of Event or Problem

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVER FLOWING. CLEANED THE INLINE FILTER. HAS TRIED REMOVING THE CONNECTORS AND FLUSHING WITH A SYRINGE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CHECKED IF INLINE FILTER WAS CLEANED. NEXT STEPS (IF NECESSARY): DISPATCH ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y, WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N, WAS THERE ANY INJURY OR POTENTIAL INJURY? N, LEAK (IF YES EXPLAIN)? Y, WASH TOWER OVERFLOWED. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? YES. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WHAT WAS THE FLUID THAT LEAKED? WASTE. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N. SOFTWARE VERSION? UNKNOWN, RESOLUTION ACHIEVED (Y/N)? N, FOLLOW UP REQUIRED (Y/N)? Y. ADDITIONALLY, ON 2020-8/13 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE FLUID WAS A COMBINATION OF WASTE, WATER AND SHEATH FLUID. THE FLUIDS WERE NOT CONTAINED IN THE SYSTEM. THE CUSTOMER WAS NOT INJURED OR HARMED AS A RESULT OF THE FLUID. THE FLUID WAS CLEANED AND DISINFECTED USING BLEACH SOLUTION.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED THAT ¿THE SPA WASH TOWER IS OVERFLOWING¿. THE FSE REPORTED THE WASH TOWER WAS OVERFLOWING DUE TO YELLOW CAP PIERCINGS CLOGGING THE FORWARD FILTER COUPLING BEFORE THE FILTER AND AFTER THE WASH TOWER. THE FLUID WAS A COMBINATION OF WASTE/WATER AND SHEATH FLUID. THE FLUIDS WERE NOT CONTAINED IN THE SYSTEM. THE CUSTOMER WAS NOT INJURED OR HARMED AS A RESULT OF THE FLUID. THE FLUID WAS CLEANED AND DISINFECTED USING BLEACH SOLUTION. THE CLOGGED COUPLING WAS REPLACED WHICH CORRECTED THE PROBLEM. THE INSTRUMENT IS WORKING TO SPECS. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. REVIEW OF THE DHR FOR SERIAL NUMBER: X0008 AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THIS COMPLAINT IS PART OF CAPA 681837.