BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT III THE WASH TOWER OVERFLOWED 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 OVERFLOWING. 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 -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? UNKNOWN. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT III THE WASH TOWER OVERFLOWED 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 OVERFLOWING. 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? UNKNOWN. 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 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 (B)(6) 2021 TO DATE (B)(6) 2022 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE (B)(4) COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2021 TO DATE (B)(6) 2022 (ROLLING 12 MONTHS) ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: THE CUSTOMER REPORTED THAT THE WASH STATION WAS OVERFLOWING. THE REPORTED PROBLEM WAS CONFIRMED; THE LEAK WAS COMING FROM THE WASH TOWER BECAUSE THE WASTE LINE WAS BACKED UP FROM BLOCKAGE IN THE WASTE PUMP HEAD ASSEMBLY. THE LEAK WAS WASTE AND FLUIDS USED FOR THE INSTRUMENT OPERATIONS SUCH AS SHEATH, DI WATER AND LYSE. THE LEAK WAS BEFORE THE WASTE TANK AND WAS NOT UNDER PRESSURE. THE CLOG IN THE WASTE PUMP HEAD WAS DUE TO CORES FROM THE YELLOW VACUTAINER CAPS. THE TUBES USED ARE BD VACUTAINER ACD SOLUTION A #364606. THE PROBE HAD 1895 PIERCINGS AND WAS LOT# F164970. 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. O 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) 2009. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION WAS OVERFLOWING O PROBLEM DESCRIPTION: WASH STATION PUMP IS CLOGGED O CAUSE: DEFECTIVE CLOGGED PUMP O WORK PERFORMED: CLEARED THE CLOGGED PUMP O SOLUTION: CLEARED THE CLOGGED PUMP ¿ RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS ¿ 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: O RISK MANAGEMENT FILE PART #100245RA, REVISION 03 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:_AFAP_____ O 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.