BD FACS SAMPLE PREP ASSISTANT

Description of Event or Problem

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVER FLOWING. CUSTOMER HAS CLEANED THE IN-LINE FILTER. CUSTOMER HAS ALSO REPLACED THE PROBE. PROBE ONLY HAS ABOUT 800 PIERCINGS. CUSTOMER RUNS THE LAVENDER TOP AND YELLOW TOP TUBES. ONLY THE YELLOW TOP CORINGS ARE BEING FOUND IN THE FILTER. FLUID WAS NOT UNDER PRESSURE AND THERE WAS NO SPRAY. LEAK (IF YES EXPLAIN)? YES, WASH TOWER OVER FLOWED. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO, LEAKED ONTO THE FLOOR. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? Y, WASH TOWER . 3. WHAT WAS THE FLUID THAT LEAKED? WASTE. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASH TOWER. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. ADDITIONALLY, ON 2020-8-28 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: I DID NOT SEE OR VERIFY WASH TOWER OVERFLOWING. IT WAS INSIDE THE INSTRUMENT ACCORDING TO THE CUSTOMER AND WAS SHEATH FLUID. DURING THE PRIME. THE CUSTOMER DID NOT COME IN CONTACT WITH IT TOO MY KNOWLEDGE.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: CUSTOMER REPORTED THAT ¿THE WASH STATION IS OVERFLOWING¿. REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. FSE FOUND RESTRICTION IN WASTE PATHWAY. FSE CLEARED RESTRICTION OUT. DID NOT SEE OR VERIFY WASH TOWER OVERFLOWING. IT WAS INSIDE THE INSTRUMENT ACCORDING TO THE CUSTOMER AND WAS SHEATH FLUID DURING THE PRIME. THE INSTRUMENT IS UP AND RUNNING AND IS NOT OVERFLOWING. BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. CAPA 681837 WAS OPENED.

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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVER FLOWING. CUSTOMER HAS CLEANED THE IN-LINE FILTER. CUSTOMER HAS ALSO REPLACED THE PROBE. PROBE ONLY HAS ABOUT 800 PIERCINGS. CUSTOMER RUNS THE LAVENDER TOP AND YELLOW TOP TUBES. ONLY THE YELLOW TOP CORINGS ARE BEING FOUND IN THE FILTER. FLUID WAS NOT UNDER PRESSURE AND THERE WAS NO SPRAY. LEAK (IF YES EXPLAIN)? Y, WASH TOWER OVER FLOWED. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO, LEAKED ONTO THE FLOOR. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? Y, WASH TOWER. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASH TOWER. 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. ADDITIONALLY, ON 2020-8-28 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: I DID NOT SEE OR VERIFY WASH TOWER OVERFLOWING. IT WAS INSIDE THE INSTRUMENT ACCORDING TO THE CUSTOMER AND WAS SHEATH FLUID. DURING THE PRIME. THE CUSTOMER DID NOT COME IN CONTACT WITH IT TO MY KNOWLEDGE.