BD FACS SAMPLE PREP ASSISTANT III

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 WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. CLOGGING IN THE WASHING STATION AND CONSEQUENTLY WETTING THE ENTIRE DECK OF THE EQUIPMENT. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? NON-WASTE LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO FLUID STATION SEWER LINE CONNECTOR WAS BROKEN.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. CLOGGING IN THE WASHING STATION AND CONSEQUENTLY WETTING THE ENTIRE DECK OF THE EQUIPMENT. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. 5. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? NON-WASTE LINE. 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. FLUID STATION SEWER LINE CONNECTOR WAS BROKEN.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: CLOGGING IN WASH STATION. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 08MAR2020 TO DATE 08MAR2021 (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 08MAR2020 TO DATE 08MAR2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE COMMENTS: CLEANING OF THE PUMP HEAD, CLEANING OF THE METAL FILTER. THE METAL FILTER INLET CONNECTOR NEEDED TO BE REMOVED AND IT WAS ADAPTED FOR OPERATION UNTIL THE MATERIAL ARRIVED, THIS CONNECTOR WAS WITH A LOT OF ACCUMULATION OF DIRT INTERNALLY. PREPARED A RACK WITH SAMPLES CORRECTLY. THE EQUIPMENT IS FUNCTIONING CORRECTLY. SYSTEM RELEASED FOR USE. NOTE: THE MALE CONNECTOR OF THE METAL FILTER WILL BE REPLACED. ADDITIONAL W/O: CLEANING AND DECONTAMINATION OF THE EQUIPMENT DECK WAS CARRIED OUT, REPLACED THE METAL FILTER CONNECTOR, REPLACED THE FEMALE CONNECTOR OF THE FLUID STATION. TESTS WERE PERFORMED AND THE REPORTED PROBLEM NO LONGER OCCURRED. THE EQUIPMENT IS FUNCTIONING CORRECTLY. SYSTEM RELEASED FOR USE. NOTE: ALL CONNECTORS IN THE WASTE LINE REPLACED DUE TO WEAR AND IMPREGNATED DIRT TO AVOID FUTURE PROBLEMS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #(B)(4). INSTALL DATE: (B)(6) 2012. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: CLOGGING IN THE WASHING STATION; PROBLEM DESCRIPTION: FLUIDICS; CAUSE: CLOGGED WASTE PUMP AND FLUIDIC LINES, CONNECTORS, FILTER; WORK PERFORMED: CLEARED FLUIDIC LINES AND CLEANED OUT PUMP AND FILTERS; SOLUTION: CLEARED FLUIDIC LINES AND CLEANED OUT PUMP AND FILTERS. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES/NO? HAZARD ID: (B)(4). HAZARD: ENVIRONMENTAL BIOHAZARD. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. RISK CONTROL: ALARP. MITIGATION(S) SUFFICIENT , YES/ NO? ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED PUMP, FLUIDIC LINE AND CONNECTORS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED FOR THE CLOGGED WASH STATION H3 OTHER TEXT : SEE H.10.