BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. CUSTOMER PROBLEM: INTERNALLY LEAKING. STEPS TAKEN WITH CUSTOMER/ TROUBLESHOOTING: INITIALLY THE ERROR "WASTE TANK FULL" APPEARED. THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY. CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. CUSTOMER REACHED OUT TO FSE (B)(6). I ASKED THE CUSTOMER TO CHECK TO SEE IF THE WASH STATION IS OVERFLOWING, UPON CHECKING THE WASTE STATION IS FULL OF FLUID. I HAD HER TRY TO CLEAN THE IN-LINE FILTER BUT SHE SAID SHE COULD NOT UNSCREW IT TO CLEAN IT. SHE WOULD LIKE THE FSE. INITIALLY THE ERROR "WASTE TANK FULL" APPEARED. THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY. CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. CUSTOMER REACHED OUT TO FSE (B)(6).

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.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY (B)(4) PN: 647205 SPAIII SN: (B)(6) AWARENESS: 10/04/2022 OPENED: 10/04/2022 INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: INTERNALLY LEAKING. MANUFACTURING DEFECT TREND: THERE ARE (B)(4) QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 04OCT2021 TO DATE 04OCT2022 (ROLLING 12 MONTHS) COMPLAINT TREND: THIS IS (B)(4) COMPLAINT RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 04OCT2021 TO DATE 04OCT2022 (ROLLING 12 MONTHS) (B)(4) (THIS COMPLAINT). INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: REPLACED WASTE FITTING (PART NO 59-10092-05S USED CUSTOMER STOCK). INSTRUMENT PASSED ALL REQUIRED TESTS. 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) 2013. DEFECTIVE PART NUMBER: 59-10092-055 WASTE FITTING. WORK ORDER NOTES: SUBJECT / REPORTED: INTERNALLY LEAKING. PROBLEM DESCRIPTION: FLUIDIC LEAK. CAUSE: COUPLING/FITTING DEFECT. WORK PERFORMED: REPLACED WASTE FITTING. SOLUTION: REPLACED WASTE FITTING. PARTS REPLACED: 59-10092-005 - WASTE FITTING . RETURNED SAMPLE ANALYSIS: THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED AND NO PHOTO(S) / PICTURE(S) WERE PROVIDED. 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: 3.1.28. HAZARD: ENVIRONMENT BIOHAZARD. CAUSE: LEAKING WASTE LINES. HARMFUL EFFECTS: EXPOSURE TO BIOHAZARD. RESIDUAL SEVERITY: 5. RESIDUAL PROBABILITY: 1. RESIDUAL 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 FSE¿S REPORT THE ROOT CAUSE WAS A DEFECTIVE WASTE FITTING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR INTERNALLY LEAKING. 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 THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT WAS REPORTED BY THE CUSTOMER THAT THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. CUSTOMER PROBLEM: INTERNALLY LEAKING STEPS TAKEN WITH CUSTOMER/ TROUBLESHOOTING: INITIALLY THE ERROR "WASTE TANK FULL" APPEARED. THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY. CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. CUSTOMER REACHED OUT TO FSE (B)(4). I ASKED THE CUSTOMER TO CHECK TO SEE IF THE WASH STATION IS OVERFLOWING, UPON CHECKING THE WASTE STATION IS FULL OF FLUID. I HAD HER TRY TO CLEAN THE IN-LINE FILTER BUT SHE SAID SHE COULD NOT UNSCREW IT TO CLEAN IT. SHE WOULD LIKE THE FSE. INITIALLY THE ERROR "WASTE TANK FULL" APPEARED. THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY. CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. CUSTOMER REACHED OUT TO FSE (B)(4).