BD FACS¿ SAMPLE PREP ASSISTANT III

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, THERE WAS A LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED: 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." IT WAS REPORTED BY THE CUSTOMER THAT THE WASH TOWER IS OVERFLOWING.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: (B)(4), PN: 647205, SPAIII SN: (B)(6), DATE REPORTED: 08/26/2022. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASTE 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 26AUG2021 TO DATE 26AUG2022 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 12 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 26AUG2021 TO DATE 26AUG2022 (ROLLING 12 MONTHS). COMPLAINT DATA ATTACHED. INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: THOROUGHLY CLEARED ALL BLOCKAGE FROM THE CLOGGED FITTING AND FLUSHED THE WASTE LINE AND FILTER. FLUID IS NOW BEING PULLED TO WASTE FROM THE WASH TOWER AS EXPECTED. NO CALIBRATED EQUIPMENT USED. CLEARING THE CLOGGED WASTE LINE FITTING RESOLVED THE REPORTED ISSUE. THE INSTRUMENT IS OPERATING AS INTENDED AND IS TESTING WITHOUT ERRORS. RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE. 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: 07DEC2015. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: WASTE TOWER IS OVERFLOWING. PROBLEM DESCRIPTION: WASH TOWER IS OVERFLOWING. CAUSE: CLOGGED WASH TOWER FLUIDIC LINE AND FILTER. WORK PERFORMED: CLEARED BLOCKAGE FROM FITTINGS AND WASTE LINE FILTER. SOLUTION: CLEARED BLOCKAGE FROM FITTINGS AND WASTE LINE FILTER RETURNED SAMPLE EVALUATION: THERE WERE NO 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 OR 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 OR NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED WASTE LINE FILTER AND FITTINGS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL 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.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III, THERE WAS A LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED: 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." IT WAS REPORTED BY THE CUSTOMER THAT THE WASH TOWER IS OVERFLOWING.