BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER IS NOT ASPIRATING. CLOGS IN THE WASTE LINE. 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE 5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID.? NO.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED THAT THE WASH TOWER IS OVERFLOWING. 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 3 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). RELATED COMPLAINT(S) NUMBER: 125712, 1256733 AND 1972325 (THIS COMPLAINT). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: FLUSHED THE WASTE LINE FILTER FITTINGS AND WASH PUMP. SOME OF THE FITTINGS WERE STILL PARTIALLY CLOGGED AND UNABLE TO BE FLUSHED: THESE WERE REPLACED (PARTS LINES PLUS NSI PN 640587.) THE INSTRUMENT WAS THEN INITIALIZED AND PRIMED MULTIPLE TIMES TO CONFIRM PROPER ASPIRATION OF THE WASH TOWER. CAUSE: CLOGS IN THE WASTE LINE. SOLUTION: FLUSHING THE WASTE LINE AND REPLACING THE CLOGGED COMPONENTS RESOLVED THE REPORTED ISSUE. THE INSTRUMENT IS OPERATING AS INTENDED AND IS TESTING WITHOUT ERRORS. I HAVE RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER # (B)(4). INSTALL DATE: DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. TUBING AND COUPLINGS WERE REPLACED TO ENSURE THE LINES WERE CLEAN. WORK ORDER NOTES: SUBJECT / REPORTED: WASH TOWER OVERFLOWING. PROBLEM DESCRIPTION: WASH TOWER OVERFLOW. CAUSE: CLOGGED LINES. WORK PERFORMED: FLUSHED THE LINE. SOLUTION: FLUSHED THE LINE. 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: RISK MANAGEMENT FILE PART # (B)(4), 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 CLOGGED WASTE LINE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH TOWER OVERFLOW. NO CAPA RATIONAL: THE COMPLAINT WAS REVIEWED, AND NO ADVERSE EVENT HAS OCCURRED AT THIS TIME. THIS COMPLAINT MODE WILL BE TRENDED, AND FURTHER INVESTIGATION WILL BE REQUIRED IF AN ACTIONABLE LEVEL IS REACHED.

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 WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER IS NOT ASPIRATING. CLOGS IN THE WASTE LINE. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIO-HAZARD. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE 5B (IF WASTE LINE); WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.