BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED OUTSIDE OF THE INSTRUMENT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE CUSTOMER REPORTS THAT AT THE END OF THE SESSION DURING THE FINAL WASH THE WASHING COLUMN WAS FILLED WITH LIQUID WHICH IS OVERFLOWED. THE CLIENT CLEANED AND DISINFECTED EVERYTHING. THE LEAKAGE WAS NOT CONTAINED WITHIN THE INSTRUMENT IN A CUSTOMER ACCESSIBLE LOCATION. THE LEAKED FLUID WAS FACSFLOW. THE SOURCE OF THE LEAK WAS A WASTE LINE. CUSTOMER WAS NOT EXPOSED TO BLOOD OR BODILY FLUIDS. THE CUSTOMER SUFFERED NO PHYSICAL HARM AS RESULT OF THE LEAK.

Additional Manufacturer Narrative

H.6. INVESTIGATION: PROBLEM STATEMENT: CUSTOMER REPORTED THAT ¿AT THE END OF A SESSION THE SPA WASH TOWER IS OVERFLOWED¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS 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). COMPLAINT TREND: THERE ARE 6 OF COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER THE FSE REPORT VERIFIED ISSUE WITH WASH STATION PUMP. MINI WASH ASSEMBLY AND FITTINGS WERE REPLACED. SYSTEM PASSED ALL REQUIRED TESTS. SPA WAS RETURNED TO LAB FOR NORMAL USE. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #(B)(4). INSTALL DATE: (B)(6) 2013. DEFECTIVE PART NUMBER: 334297. WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION OVERFLOWED. PROBLEM DESCRIPTION: WASH STATION WAS OVERFLOWING. CAUSE: WASH STATION PUMP FAILURE. WORK PERFORMED: REPLACED MINIWASH STATION. SOLUTION: REPLACE MINIWASH STATION. RETURNED SAMPLE EVALUATION: PER FSE THE MINIWASH PUMP WAS DEFECTIVE. FSE RESOLVED THE ISSUE BY REPLACING THE MINIWASH STATION. RETURN OF THE DEFECTIVE PART IS NOT REQUIRED. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES? NO? HAZARD ID: 3.1.29. HAZARD: ENVIRONMENTAL BIOHAZARD. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. RISK CONTROL:_ALARP. MITIGATION(S) SUFFICIENT YES? NO? ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS THE WASTE PUMP WAS DEFECTIVE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED.

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 THE INSTRUMENT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CUSTOMER REPORTS THAT AT THE END OF THE SESSION DURING THE FINAL WASH THE WASHING COLUMN WAS FILLED WITH LIQUID WHICH IS OVERFLOWED. THE CLIENT CLEANED AND DISINFECTED EVERYTHING. THE LEAKAGE WAS NOT CONTAINED WITHIN THE INSTRUMENT IN A CUSTOMER ACCESSIBLE LOCATION. THE LEAKED FLUID WAS FACSFLOW. THE SOURCE OF THE LEAK WAS A WASTE LINE. CUSTOMER WAS NOT EXPOSED TO BLOOD OR BODILY FLUIDS. THE CUSTOMER SUFFERED NO PHYSICAL HARM AS RESULT OF THE LEAK.