BD FACS¿ SAMPLE PREP ASSISTANT III

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: "WASH TOWER OVERFLOWING. 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): BIOHAZARD. 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. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? (IF NO, GO TO QUESTION #7. IF MIXED WITH DECONTAMINATION, NO FURTHER QUESTIONS REQUIRED.): NO. "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. PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN.".

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. 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: "WASH TOWER OVERFLOWING 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.) NO "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 PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN."

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: (B)(4), PN: 647205, SPAIII, SN: (B)(6), DATE REPORTED: 06/07/2022. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH TOWER IS OVERFLOWING. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 07JUN2021 TO DATE 07JUN2022 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 13 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 07JUN2021 TO DATE 07JUN2022 (ROLLING 12 MONTHS) O COMPLAINT DATA ATTACHED. INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: CLEARED THE CLOG FROM THE WASTE PUMP VALVES. VERIFIED PROPER WASTE SYSTEM FLOW FROM THE WASH TOWER WITH MULTIPLE SYSTEM PRIMES. AFTER CLEARING THE CLOGGED WASTE PUMP, THE REPORTED ISSUE WAS RESOLVED. RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE. 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: 18SEP2009; DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: O SUBJECT / REPORTED: WASH TOWER IS OVERFLOWING O PROBLEM DESCRIPTION: WASH TOWER OVERFLOWING O CAUSE: CLOGGED WASTE PUMP VALVES O WORK PERFORMED: CLEARED THE CLOG FROM THE WASTE PUMP VALVE O SOLUTION: CLEARED THE CLOG FROM THE WASTE PUMP VALVE. 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. HAZARD(S) IDENTIFIED? YES NO. HAZARD ID: (B)(6). HAZARD: ENVIRONMENTAL BIOHAZARD SEVERITY: (B)(4). PROBABILITY: (B)(4). RISK INDEX: (B)(4). 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 A CLOGGED WASTE PUMP VALVE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR WASH TOWER OVERFLOWING. 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.