BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY (B)(4), PN: 647205, SPAIII, SN: (B)(6), DATE REPORTED: 09/09/2022. INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: LEAKING LIQUID FROM WASH COLUMN. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 09SEP2021 TO DATE 09SEP2022 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 4 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 09SEP2021 TO DATE 09SEP2022 (ROLLING 12 MONTHS). COMPLAINT DATA ATTACHED. INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: FOUND THE PRESENCE OF RUBBER PARTS FROM PERFORATION OF THE SAMPLE TUBE OBSTRUCTING THE DRAIN. CLEAN CHECKED THAT THE LIQUID FLOWED OPTIMALLY. REPLACED SAMPLE NEEDLE SUPPLIED TO THE CUSTOMER THE INSTRUMENT IS FULLY FUNCTIONAL 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: 08JUN2020 DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: SUBJECT / REPORTED: WASTE TOWER IS LEAKING FLUID PROBLEM DESCRIPTION: WASH TOWER IS LEAKING FLUID CAUSE: CLOGGED WASH TOWER DRAIN WORK PERFORMED: CLEARED BLOCKAGE FROM THE DRAIN SOLUTION: CLEARED BLOCKAGE FROM THE DRAIN RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(4) 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 WASTE DRAIN CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE CALL REPORT THE COMPLAINT WAS CONFIRMED FOR WASH TOWER LEAKING FLUID. 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 THAT THE INSTRUMENT IS LEAKING LIQUID FROM THE WASHING COLUMN AND THAT NO LIQUID IS MOVING TOWARDS THE WASTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT THE CUSTOMER REPORTS THAT THE INSTRUMENT IS LEAKING LIQUID FROM THE WASHING COLUMN AND THAT NO LIQUID IS MOVING TOWARDS THE WASTE. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIO- HAZARD BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH ? NO. WAS THE CUSTOMER OR BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID ? NO.

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE INSTRUMENT IS LEAKING LIQUID FROM THE WASHING COLUMN AND THAT NO LIQUID IS MOVING TOWARDS THE WASTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER THAT THE CUSTOMER REPORTS THAT THE INSTRUMENT IS LEAKING LIQUID FROM THE WASHING COLUMN AND THAT NO LIQUID IS MOVING TOWARDS THE WASTE. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIO- HAZARD BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH ? NO. WAS THE CUSTOMER OR BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID ? NO.