BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. DEVICE EVALUATED BY MFR: 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 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: 1. WAS THE LEAK FLUID OR AIR? (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.)LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.)NOT CONTAINED. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? (IF YES DESCRIBE THE FLUID THAT SPRAYED THEN GO TO QUESTION #7, IF NO, GO TO QUESTION #4)NO. 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD, GO TO QUESTION #5)BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6)BEFORE WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAMINATION, NO FURTHER QUESTIONS REQUIRED.). "7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO CONTACT, NO FURTHER QUESTIONS REQUIRED.)NO. CALLER HAS EMAILED IN THAT THERE IS A LEAK ON THEIR SYSTEM.

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: 1. WAS THE LEAK FLUID OR AIR? (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.)LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.)NOT CONTAINED. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? (IF YES DESCRIBE THE FLUID THAT SPRAYED THEN GO TO QUESTION #7, IF NO, GO TO QUESTION #4)NO. 4. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD, GO TO QUESTION #5)BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6)BEFORE WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAIMINATION, NO FURTHER QUESTIONS REQUIRED.) "7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO CONTACT, NO FURTHER QUESTIONS REQUIRED.)NO. CALLER HAS EMAILED IN THAT THERE IS A LEAK ON THEIR SYSTEM.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY (B)(4) PN: 647205 SPAIII SN: (B)(6) DATE REPORTED: (B)(6) 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: LEAK ON THE SYSTEM. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2021 TO DATE (B)(6) 2022 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 7 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2021 TO DATE (B)(6) 2022 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: FILTER CLOGGED CAUSING THE WASH STATION TO DRAIN SLOWLY, CLEANED FILTER, CHECKED FITTING WITH A SYRINGE TO MAKE SURE NOT RESTRICTED, CHECKED WASH STATION TO MAKE SURE NO RESTRICTIONS, VERIFIED PERFORMANCE WITH A&P, VERIFIED PROBE CALIBRATION. NO FURTHER ISSUES, 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# (B)(4). INSTALL DATE: (B)(6) 2018. DEFECTIVE PART NUMBER: 640835-INLINE FILTER KIT. WORK ORDER NOTES: SUBJECT / REPORTED: LEAKING FROM SYSTEM. PROBLEM DESCRIPTION: FLUID LEAK. CAUSE: CLOGGED INLINE FILTER. WORK PERFORMED: REPLACED INLINE FILTER. SOLUTION: REPLACED 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 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:AFAP. MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED INLINE FILTER. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR LEAK FROM SYSTEM. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10.