BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

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 (B0(6)2021 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 9 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) COMPLAINT DATA ATTACHED. INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACED PUMP AND FILTER. INSTRUMENT IN FINE WORKING ORDER AFTER REPAIR. NO OTHER INFORMATION AVAILABLE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(4)2015. DEFECTIVE PART NUMBER: 334297. MINIWASH ASSEMBLY ¿ 640835. SPA INLINE FILTER KIT WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS OVERFLOWING. PROBLEM DESCRIPTION: FLUIDIC CLOG. CAUSE: CLOGGED INLINE FILTER. WORK PERFORMED: REPLACED PUMP AND INLINE FILTER . SOLUTION: REPLACED PUMP AND INLINE FILTER . 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 CLOGGED PUMP AND INLINE 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 THE WASH STATION OF A BD FACS¿ SAMPLE PREP ASSISTANT III WAS LEAKING BIOHAZARDOUS WASTE. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WASH STATION IS OVERFLOWING. THE IN-LINE FILTER SEEMS TO BE LEAKING AS WELL. 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? BEFORE WASTE LINE . 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH?. 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

Additional Manufacturer Narrative

INVESTIGATION: ¿ 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 14OCT2020 TO DATE 14OCT2021 (ROLLING 12 MONTHS) ¿ COMPLAINT TREND: THERE ARE 9 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: REPLACED PUMP AND FILTER. INSTRUMENT IN FINE WORKING ORDER AFTER REPAIR. NO OTHER INFORMATION AVAILABLE. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02156483 INSTALL DATE: 29SEP2015 DEFECTIVE PART NUMBER: 334297 MINIWASH ASSEMBLY ¿ 640835 SPA INLINE FILTER KIT WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS OVERFLOWING PROBLEM DESCRIPTION: FLUIDIC CLOG CAUSE: CLOGGED INLINE FILTER WORK PERFORMED: REPLACED PUMP AND INLINE FILTER SOLUTION: REPLACED PUMP AND INLINE FILTER ¿ 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) AND PN647205 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:_ALARM_____ MITIGATION(S) SUFFICIENT YES. NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED PUMP AND INLINE 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 THE WASH STATION OF A BD FACS¿ SAMPLE PREP ASSISTANT III WAS LEAKING BIOHAZARDOUS WASTE. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WASH STATION IS OVERFLOWING. THE IN-LINE FILTER SEEMS TO BE LEAKING AS WELL. 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? BEFORE WASTE LINE . 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

Description of Event or Problem

IT WAS REPORTED THAT THE WASH STATION OF A BD FACS¿ SAMPLE PREP ASSISTANT III WAS LEAKING BIOHAZARDOUS WASTE. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WASH STATION IS OVERFLOWING. THE IN-LINE FILTER SEEMS TO BE LEAKING AS WELL. 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? BEFORE WASTE LINE. 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

Additional Manufacturer Narrative

H.6. INVESTIGATION: 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 14OCT2020 TO DATE 14OCT2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 9 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 14OCT2020 TO DATE 14OCT2021 (ROLLING 12 MONTHS) . INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACED PUMP AND FILTER. INSTRUMENT IN FINE WORKING ORDER AFTER REPAIR. NO OTHER INFORMATION AVAILABLE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(6) 2015. DEFECTIVE PART NUMBER: 334297 MINIWASH ASSEMBLY ¿ 640835 SPA INLINE FILTER KIT. WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS OVERFLOWING; PROBLEM DESCRIPTION: FLUIDIC CLOG; CAUSE: CLOGGED INLINE FILTER; WORK PERFORMED: REPLACED PUMP AND INLINE FILTER; SOLUTION: REPLACED PUMP AND INLINE FILTER. 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) AND PN647205 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; HAZARD ID: (B)(4). 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 PUMP AND INLINE FILTER. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW.

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 THE WASH STATION OF A BD FACS¿ SAMPLE PREP ASSISTANT III WAS LEAKING BIOHAZARDOUS WASTE. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE WASH STATION IS OVERFLOWING. THE IN-LINE FILTER SEEMS TO BE LEAKING AS WELL. 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? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.