BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: X0402 PROBLEM STATEMENT: CUSTOMER REPORTED: LIQUID LEAK FROM THE STATION. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 16MAR2020 TO DATE 16MAR2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 5 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 16MAR2020 TO DATE 16MAR2021 (ROLLING 12 MONTHS) . INVESTIGATION RESULT / ANALYSIS: PER FSE COMMENTS: THE CUSTOMER REPORTS A LIQUID LEAK FROM THE STATION EVEN THOUGH THE INSTRUMENT IS WORKING PROPERLY. GENERAL CHECK OF THE INSTRUMENT. REPLACEMENT OF THE WASTE PANEL FITTING (591018105). FLUIDIC CIRCUIT CONTROL. TESTS WITH COMPLETE RACK CARRIED OUT WITH REGULAR RESULTS. CHECKED FOR CORRECT OPERATION, SYSTEM IN USE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER (B)(4). INSTALL DATE: 22OCT2015. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: O SUBJECT / REPORTED: LEAK AT STATION. O PROBLEM DESCRIPTION: FLUIDICS. O CAUSE: UNDETERMINED. O WORK PERFORMED: CLEARED FLUIDIC LINES AND CLEANED FITTINGS. O SOLUTION: CLEARED FLUIDIC LINES AND CLEANED FITTINGS. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: O RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES, NO ¿ HAZARD ID: 3.1.29 . ¿ HAZARD: ENVIRONMENTAL BIOHAZARD. ¿ SEVERITY: 5. ¿ PROBABILITY: 1. ¿ RISK INDEX: 5. O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. O RISK CONTROL:_ALARP. O MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE CANNOT BE DETERMINED. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS UNCONFIRMED FOR THE LEAK AT THE WASH STATION .

Description of Event or Problem

IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE CUSTOMER REPORTS A LIQUID LEAK FROM THE STATION EVEN THOUGH THE INSTRUMENT IS WORKING PROPERLY. 1. WAS THE LEAK LIQUID OR AIR? - LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? - NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? - NO. 4. WHAT WAS THE FLUID THAT LEAKED? - BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? - AFTER WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? - NO. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? - NO.

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.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE CUSTOMER REPORTS A LIQUID LEAK FROM THE STATION EVEN THOUGH THE INSTRUMENT IS WORKING PROPERLY. WAS THE LEAK LIQUID OR AIR? - LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? - NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? - NO. WHAT WAS THE FLUID THAT LEAKED? - BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? - AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? - NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? - NO.