BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID LEAKAGE FROM WASHING TURRET. CUSTOMER HAS REPLACED THE METAL FILTER WHICH IS STILL WASHED EVERY DAY BUT THE PROBLEM PERSISTS. WAS THE LEAK LIQUID OR AIR? IF LIQUID/BOTH, GO TO QUESTION, IF AIR, NO FURTHER QUESTIONS REQUIRED. LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? IF NOT CONTAINED, GOT TO QUESTION, IF CONTAINED, NO FURTHER QUESTIONS REQUIRED. NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION, IF NO, TYPE ¿NO¿ IN THE TEXT BOX THEN GO TO QUESTION, NO. WHAT WAS THE FLUID THAT LEAKED? IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION, BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE: IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION, IF AFTER WASTE LINE, GO TO QUESTION #6. BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? IF NO, GO TO QUESTION, IF YES, NO FURTHER QUESTIONS REQUIRED. NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? IF YES, GOT TO QUESTION, IF NO, NO FURTHER QUESTIONS REQUIRED. PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN. NO.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID LEAKAGE FROM WASHING TURRET. CUSTOMER HAS REPLACED THE METAL FILTER (WHICH IS STILL WASHED EVERY DAY) BUT THE PROBLEM PERSISTS. 1. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? (IF NOT CONTAINED, GOT TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE ¿NO¿ IN THE TEXT BOX THEN GO TO QUESTION #4): NO. 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE: (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): BEFORE WASTE LINE 6. WAS THE WASTE MIXED WITH DECON.TAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GOT TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO."

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL? YES. D.9 RETURNED TO MANUFACTURER ON: 06-MAY-2022. H.2 DEVICE RETURN TO MANUF .?: NO. H.2 DEVICE EVAL BY MANUFACTURER?: YES. (B)(4). PN: 647205 SPAIII SN: (B)(6). DATE REPORTED: 05/02/2022. INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED: LIQUID LEAKING FROM WASHING TOWER. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 02MAY2021 TO DATE 02MAY2022 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE 13 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 02MAY2021 TO DATE 02MAY2022 (ROLLING 12 MONTHS). O COMPLAINT DATA ATTACHED. ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: CUSTOMER REPORTED LIQUID LEAKING FROM THE WASH TOWER. CHECK THE DEFECT, THE PROBLEM WAS SOLVED BY REPLACING THE MINIWASH ASSEMBLY PN 334297, CHECKED THE PROPER FUNCTIONING OF THE EQUIPMENT. O SAMPLE PREPARATION WAS NOT AFFECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02432310. INSTALL DATE: 07MAR2019. DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH ASSEMBLY. WORK ORDER NOTES: O SUBJECT / REPORTED: LIQUID LEAKING FROM WASH TOWER. O PROBLEM DESCRIPTION: FLUID LEAKAGE. O CAUSE: DEFECTIVE MINIWASH ASSEMBLY. O WORK PERFORMED: REPLACED MINIWASH ASSEMBLY. O SOLUTION: REPLACED MINIWASH ASSEMBLY. ¿ RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PART. ¿ 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 03 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES OR NO? HAZARD ID: (B)(4). HAZARD: ENVIRONMENTAL BIOHAZARD. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. O RISK CONTROL: AFAP. O MITIGATION(S) SUFFICIENT: YES OR NO? ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A DEFECTIVE MINIWASH ASSEMBLY. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR FLUID LEAKAGE FROM THE WASH TOWER. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY.

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: LIQUID LEAKING FROM WASHING TOWER ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 02 MAY 2021 TO DATE 02 MAY 2022 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE 13 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 02 MAY 2021 TO DATE 02 MAY 2022 (ROLLING 12 MONTHS). ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: CUSTOMER REPORTED LIQUID LEAKING FROM THE WASH TOWER. CHECK THE DEFECT, THE PROBLEM WAS SOLVED BY REPLACING THE MINIWASH ASSEMBLY PN 334297, CHECKED THE PROPER FUNCTIONING OF THE EQUIPMENT. O SAMPLE PREPARATION WAS NOT AFFECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02432310. INSTALL DATE: 07 JUL 2019. DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH ASSEMBLY. WORK ORDER NOTES: O SUBJECT / REPORTED: LIQUID LEAKING FROM WASH TOWER. O PROBLEM DESCRIPTION: FLUID LEAKAGE. O CAUSE: DEFECTIVE MINIWASH ASSEMBLY. O WORK PERFORMED: REPLACED MINIWASH ASSEMBLY. O SOLUTION: REPLACED MINIWASH ASSEMBLY. ¿ RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PART. ¿ 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 03 WAS REVIEWED. O: HAZARD(S) IDENTIFIED? YES OR NO? O: HAZARD ID: 3.1.29. O: HAZARD: ENVIRONMENTAL BIOHAZARD. O: SEVERITY: 5. O: PROBABILITY: 1. O: RISK INDEX: 5. O: IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. O: RISK CONTROL:_AFAP. O: MITIGATION(S) SUFFICIENT: YES OR NO? ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A DEFECTIVE MINIWASH ASSEMBLY. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR FLUID LEAKAGE FROM THE WASH TOWER. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID LEAKAGE FROM WASHING TURRET. CUSTOMER HAS REPLACED THE METAL FILTER (WHICH IS STILL WASHED EVERY DAY) BUT THE PROBLEM PERSISTS. 1. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? (IF NOT CONTAINED, GOT TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE ¿NO¿ IN THE TEXT BOX THEN GO TO QUESTION #4): NO. 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE: (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): BEFORE WASTE LINE 6. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GOT TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO."