BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS 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 THAT BD FACS¿ SAMPLE PREP ASSISTANT III WAS LEAKING BIOHAZARD THAT WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE. WHAT IS THE SOURCE OF LEAK/SPILL? WASTE OR NON-WASTE LINE. WASTE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. LEAK OR DRIP WAS UNDER PRESSURE BUT WAS NOT SPRAYING NOR SQUIRTING NOR PULSING NOR OOZING. LEAK WAS JUST LEAKING/DRIPPING."

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION 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) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 11 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACEMENT OF FILTER AND MAIN WASTE PUMP TO PREVENT WASH STATION OVERFLOW. PURGED FLUIDICS AFTER THE REPLACEMENT, VERIFIED PERFORMANCE SIMULATING A SAMPLE PREPARATION RUN, INSTRUMENT WORKING CORRECTLY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(6) 2020. DEFECTIVE PART NUMBER: 334297-MINIWASH ASSEMBLY, 640835-SPA INLINE FILTER KIT. WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS OVERFLOWING. PROBLEM DESCRIPTION: WASH STATION IS OVERFLOWING. CAUSE: CLOGGED WASTE PUMP AND FILTER. WORK PERFORMED: REPLACED FILTER AND PUMP. SOLUTION: REPLACED FILTER AND PUMP. RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PARTS 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 03 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 A CLOGGED WASTE PUMP AND FILTER CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW.

Description of Event or Problem

IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III WAS LEAKING BIOHAZARD THAT WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING. WAS THERE A FLUIDIC LEAK OR SPILL? YES. 1. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO 2. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES 3. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE 4. WHAT IS THE SOURCE OF LEAK/SPILL? WASTE OR NON-WASTE LINE. WASTE 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 7. LEAK OR DRIP WAS UNDER PRESSURE BUT WAS NOT SPRAYING NOR SQUIRTING NOR PULSING NOR OOZING. LEAK WAS JUST LEAKING/DRIPPING."