BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT THE WET CART LEAKED WASTE OUTSIDE OF INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WET CART WASTE CONNECTION LEAK. WAS THE LEAK FLUID OR AIR? (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.) LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? (IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.) NOT CONTAINED. 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. WHAT WAS THE FLUID THAT LEAKED? (IF NON-BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD, GO TO QUESTION #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) NON BIOHAZARD. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAMINATION, NO FURTHER QUESTIONS REQUIRED.) AFTER WASTE LINE. 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.

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 WET CART LEAKED WASTE OUTSIDE OF INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WET CART WASTE CONNECTION LEAK. 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). 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) NON BIOHAZARD. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAMINATION, NO FURTHER QUESTIONS REQUIRED.) AFTER WASTE LINE. 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.

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: WET CART CONNECTION LEAK. ¿ 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 (B)(4) 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 REPORT: THE CUSTOMER REPORTED THE WET CART CONNECTION LEAK. QUICK CONNECT ON WASTE LINE AT FLUIDIC TANK HAD FAILED. REPLACE QUICK CONNECT FROM COUNTRY STOCK. PRIME SYSTEM. NO FURTHER ISSUES. THE PROBLEM WAS CORRECTED AND THERE WAS NO FURTHER LEAKING. 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# (B)(4). INSTALL DATE: (B)(6) 2017. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: O SUBJECT / REPORTED: WET CART CONNECTION LEAK. O PROBLEM DESCRIPTION: WET CART CONNECTION LEAK. O CAUSE: DEFECTIVE QUICK CONNECT COUPLING. O WORK PERFORMED: REPLACED QUICK CONNECT COUPLING. O SOLUTION: REPLACED QUICK CONNECT COUPLING. ¿ RETURNED SAMPLE EVALUATION: THERE WERE NO 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: O RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES NO HAZARD ID: 3.1.29 _ 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 NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A DEFECTIVE QUICK CONNECT COUPLING. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WET CART CONNECTION LEAK. 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.