BD FACS¿ SAMPLE PREP ASSISTANT

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT THE WASH TOWER WAS OVERFLOWING AND BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE WASH TOWER IS OVER FLOWING. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT THE WASH TOWER WAS OVERFLOWING AND BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE WASH TOWER IS OVER FLOWING. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 650686 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION IS OVERFLOWING. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 10MAR2021 TO DATE 10MAR2022 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 9 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 10MAR2021 TO DATE 10MAR2022 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: THE CUSTOMER REPORTED THAT THE WASH STATION WAS OVERFLOWING. FOUND POOR ASPIRATION FROM WASTE PUMP. OPENED WASTE PUMP AND CLEANED DEBRIS OFF FLAPPERS. WASTE PRESSURE PROPER AFTER CLEANING AND STATION DID NOT OVERFLOW. RAN SAMPLE AND LYSE DISPENSE-PASSED BUT SAMPLE SYRINGE WAS SQUEAKING. REPLACED SYRINGE PUMP PN647348. THE INSTRUMENT WAS TESTED AND VERIFIED AS OPERATING TO SPECS. THE PROBLEM WAS CORRECTED AND THERE WAS NO FURTHER LEAKING OR BLOCKAGE. 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) 2006. DEFECTIVE PART NUMBER: 647348-SPA SYRINGE 1ML XLP WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION WAS OVERFLOWING, PROBLEM DESCRIPTION: WASH STATION PUMP IS CLOGGED, CAUSE: CLOGGED PUMP, WORK PERFORMED: CLEARED THE CLOGGED PUMP, SOLUTION: CLEARED THE CLOGGED PUMP. RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PART. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN650686 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: (B)(6) 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 A CLOGGED WASTE PUMP. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOWING. 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. H3 OTHER TEXT : SEE H.10.