BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE RUNNING 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: IT WAS REPORTED BY THE CUSTOMER THAT THE WASH STATION IS OVERFLOWING. LEAK QUESTIONS IN SMAX: WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID? YES, LEAK WAS JUST LEAKING/DRIPPING/OVERFLOWING. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: WASH STATION IS OVERFLOWING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATED THE INLINE FILTER IS NEW AND THE WASH TOWER IS CLEAN NEXT STEPS (IF NECESSARY): DISPATCH ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? YES. SOFTWARE VERSION? NO. LIST OF PARTS SHIPPED (INCLUDE FOC): NO. RMA REQUIRED? NO. WAS THERE A FLUIDIC LEAK OR SPILL? YES. 1.WAS THERE SPRAY OF FLUID UNDER PRESSURE? YES. 2. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. 3. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. 4. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE / SHEATH 5. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE LINE 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. IS INSTRUMENT ASSURITY LINC ENABLED? NO CUSTOMER PROBLEM: EMAIL-WASH STATION IS OVERFLOWING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: EMAIL-WASH STATION IS OVERFLOWING. REPEAT PROBLEM. NEXT STEPS (IF NECESSARY): DISPATCH FSE. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TESTS? NO. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? N/A. SOFTWARE VERSION? DIVA 9 LIST OF PARTS SHIPPED (INCLUDE FOC): N/A RMA REQUIRED? N/A WAS THERE A FLUIDIC LEAK OR SPILL? YES. NO ERRONEOUS RESULTS, NO ONE WAS INJURED IN THE MAKING OF THIS CASE & THERE WERE NO BURNING SMELLS OR ODD SOUNDS. 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/OVERFLOWING.

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 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 20 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: REPAIR/TROUBLESHOOTING PERFORMED: CLEANED DEBRIS FROM MINI-WASH WASTE PUMP, IN-LINE FILTER, AND WASH STATION. VERIFIED INSTRUMENT PERFORMANCE. NO ONE WAS EXPOSED TO ANY BIO-HAZARDOUS MATERIAL SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(6). INSTALL DATE: (B)(6) 2009 DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION OVERFLOW PROBLEM DESCRIPTION: WASH STATION OVERFLOW CAUSE: CLOGGED WASH PUMP AND FILTERS WORK PERFORMED: CLEANED CLOGGED WASH PUMP AND FILTERS SOLUTION: CLEANED CLOGGED WASH PUMP AND FILTERS RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND (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 COMMENTS THE ROOT CAUSE WAS CLOGGED WASH PUMP AND FILTERS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW H3 OTHER TEXT : SEE H10.

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 THAT WHILE RUNNING 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: IT WAS REPORTED BY THE CUSTOMER THAT THE WASH STATION IS OVERFLOWING. LEAK QUESTIONS IN SMAX: WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID? YES, LEAK WAS JUST LEAKING/DRIPPING/OVERFLOWING. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: WASH STATION IS OVERFLOWING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER STATED THE INLINE FILTER IS NEW AND THE WASH TOWER IS CLEAN. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? YES. SOFTWARE VERSION? NO. LIST OF PARTS SHIPPED (INCLUDE FOC): NO. RMA REQUIRED? NO. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? 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 / SHEATH. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE LINE. 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. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: EMAIL-WASH STATION IS OVERFLOWING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: EMAIL-WASH STATION IS OVERFLOWING. REPEAT PROBLEM. NEXT STEPS (IF NECESSARY): DISPATCH FSE. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TESTS? NO. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? N/A. SOFTWARE VERSION? (B)(4). LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED? N/A. WAS THERE A FLUIDIC LEAK OR SPILL? YES. NO ERRONEOUS RESULTS, NO ONE WAS INJURED IN THE MAKING OF THIS CASE & THERE WERE NO BURNING SMELLS OR ODD SOUNDS. 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/OVERFLOWING.