BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE RUNNING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVERFLOWING. CLEANING FILTER DOESN'T HELP. 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. 6. 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: 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 (B)(6) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS) ¿ COMPLAINT TREND: THERE ARE 20 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 16JUL2020 TO DATE 16JUL2021 (ROLLING 12 MONTHS) ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: THE OVERFLOW WAS COMING FROM THE WASH TOWER BECAUSE THE WASTE LINE WAS BACKED UP FROM BLOCKAGE IN THE WASTE PUMP HEAD ASSEMBLY. THERE WAS NO BODILY CONTACT OR HARM TO THE CUSTOMER OR FSE CAUSED BY THE LEAK HOWEVER THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. BLEACH WAS USED TO CLEAN AND DISINFECT THE INSTRUMENT AND SURROUNDING AREAS. THE CLOG IN THE WASTE PUMP HEAD WAS DUE TO CORES FROM THE YELLOW VACUTAINER CAPS. THE BLOCKAGE WAS CLEARED AFTER DISASSEMBLING THE HEAD AND FLUSHING WITH DI WATER. THE PUMP WAS REASSEMBLED, AND THE COUPLINGS WERE REPLACED TO AVOID ANY FURTHER CORES FROM GOING DOWNSTREAM PAST THE FILTER. THE FILTER WAS INSPECTED. THE INSTRUMENT WAS TESTED AND VERIFIED AS OPERATING TO SPECS. THE PROBLEM WAS CORRECTED AND THERE WAS NO FURTHER LEAKING OR BLOCKAGE. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02026416 INSTALL DATE: 31JAN2018 DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: O SUBJECT / REPORTED: WASH TOWER OVERFLOWING O PROBLEM DESCRIPTION: WASH STATION DOES NOT DRAIN O CAUSE: CLOGGED WASTE PUMP FILTER AND CONNECTORS O WORK PERFORMED: CLEANED PUMP FILTER AND REPLACED CONNECTORS O SOLUTION: CLEANED PUMP FILTER AND REPLACED CONNECTORS ¿ RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: R0509 AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ RISK ANALYSIS: O RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. O HAZARD(S) IDENTIFIED? ¿YES ¿NO ¿ HAZARD ID: 3.1.29 _ ¿ HAZARD: ENVIRONMENTAL BIOHAZARD ¿ SEVERITY: 5 ¿ PROBABILITY: 1 ¿ RISK INDEX: 5 O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__ O RISK CONTROL:_ALARP_____ O MITIGATION(S) SUFFICIENT ¿YES ¿NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S COMMENTS THE ROOT CAUSE WAS CLOGGED PUMP FILTER AND CONNECTORS ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH TOWER OVERFLOWING SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE RUNNING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVERFLOWING. CLEANING FILTER DOESN'T HELP. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE. (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. WAS THE CUSTOMER/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. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.