BD ACCURI¿

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD ACCURI C6 PLUS SYSTEM, PART # 660517, AND SERIAL # (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING A WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM (B)(6) 2020 TO DATE (B)(6) 2021. COMPLAINT TREND: THERE ARE 3 COMPLAINTS RELATED A WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT; DATE RANGE FROM (B)(6) 2020 TO DATE (B)(6) 2021. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #660517, SERIAL # (B)(6), FILE #659180-659180-R659180000277-105839695-18, WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOGGED VALVE. THE CUSTOMER HAD INITIALLY REPORTED THAT THEIR LOANER INSTRUMENT WAS LEAKING FROM THE BOTTOM OF THE INSTRUMENT DURING THE CLEANING CYCLE. THEY HAD FOUND THAT ONE OF THE RED TUBINGS CONNECTED TO THE PARASITOTIC PUMP HAD DISCONNECTED. THE FSE (FIELD SERVICE ENGINEER) THAT CAME ONSITE DETERMINED THAT THE LEAKAGE WAS DUE TO CLOGGED VALVES AND REPLACED THEM (PN 658455, 658454). NEXT, THE FSE REPLACED THE FLUIDICS HARNESS (PN 659606) TO PASS SPECIFICATIONS. FINALLY, PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE INSTRUMENT AND THE FSE REPLACED HALF SHELL FILTERS (PN 660322), IN-LINE SHEATH FILTERS (PN 653148), AND A PERISTALTIC TUBING (PN 659522). NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. AFTER THE REPAIR, THE INSTRUMENT WAS TESTED AND FUNCTIONING AS EXPECTED. ALTHOUGH THERE WAS A LEAKAGE OF BIOHAZARDOUS MATERIAL, THE CUSTOMER CONFIRMED THAT NO ONE CAME IN CONTACT WITH THE LEAKED MATERIAL AND WERE NOT HARMED IN ANY WAY. ADDITIONALLY, THE LEAKAGE WAS NOT UNDER PRESSURE AND THUS DID NOT INCREASE THE RISK OF EXPOSURE. THIS INSTRUMENT WAS AN RUO, OR RESEARCH USE ONLY INSTRUMENT AND THUS THERE WAS NO INVOLVEMENT OR IMPACT TO ANY PATIENTS. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN HELP MAINTAIN THE INSTRUMENT, AND CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD ACCURI¿ C6 PLUS SYSTEM USER¿S GUIDE, #23-18013-01. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 02200857, CASE # (B)(4). INSTALL DATE: 14DEC2018 DEFECTIVE PART NUMBER: 659606 - HARNESS FLUIDICS WITH SHUT OFF VALVES 659522 - ASSY TUBING PUMP PERISTALTIC 658455 - VALVE R 12VDC VAC TO 30 PSIG 1/16 ID 3-W 658454 - VALVE 12VDC VAC TO 30 PSIG 1/16 ID 2W NC WORK ORDER NOTES: SUBJECT / REPORTED: CUSTOMER REPORTS THAT THE LOANER ACCURI IS LEAKING PROBLEM DESCRIPTION: CUSTOMER REPORTS THAT THE LEAK IS COMING FROM THE BOTTOM OF THE CLEANING CYCLE - ONE OF THE RED TUBINGS FROM THE PARASTOLIC PUMP HAD POPPED OFF WORK PERFORMED: REPLACE VALVES (CLOGGED. REPLACED COMPONENTS TO PASS SPECIFICATIONS: FLUIDICS HARNESS. REPLACED PREVENTIVE MAINTENANCE COMPONENTS: FILTER HALF SHELL (3). FILTER IN-LINE SHEATH (1). ASSY TUBING PUMP PERISTALTIC CAUSE: THE VALVE CLOG NEEDS TO REPLACE. ONE OF THE RED TUBINGS HAD POPPED OFF --> CHANGE THE NEW FLUIDIC HARNESS SOLUTION: ABLE TO REPRODUCE CUSTOMER COMPLAINTS. THE INSTRUMENT PASSES ALL SPECIFICATIONS. RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000214703, REV. 01/VERS. A, BD ACCURI C6 PLUS FLOW CYTOMETER WITH OPTIONAL BD CSAMPLER PLUS RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO. ID: 2.1.2. HAZARD: EXPOSRUE TO BIO-HAZARDOUS MATERIAL DURING PREVENTATIVE MAINTENANCE CAUSE OF EVENT: USER SPILLS SAMPLE WASTE FLUID WHILE CHANGING THE PUMP TUBING IN THE WASTE PUMPS PERISTALTIC PUMP. HARMFUL EFFECTS: EXPOSURE TO BIOHAZARDOUS MATERIAL RISK CONTROL(S): PCYT-648 ¿ LABELING BIOHAZARD¿ PCYT-3054 ¿ LABELING WASTE PUMP BIOHAZARD ¿ SY-3126 ¿ SAFETY - BIOHAZARD ¿ USER WILL APPLY THE UNIVERSAL PRECAUTION - INSTRUCTIONS FOR USE GUIDE - CHAPTER ON MAINTENANCE ¿ WEAR SUITABLE PPE ¿ BIOLOGICAL SAFETY ¿ SAFETY AND LIMITATIONS GUIDE IMPLEMENTATION VERIFICATION: ¿ MPI 7100279 ¿ MPI, ASSY., CASE, C6 ¿ 23-14661-00 BD FACSVIA¿ SAFETY AND LIMITATIONS ¿ MPI7100337 ¿ MPI, ASSY, INNER CHASSIS, MG ¿ SEE PCYT-648 23-14662-00 BD FACSVIA¿ INSTRUCTIONS FOR USE EFFECTIVE VERIFICATION: SAME AS IMPLEMENTATION VERIFICATION PROBABILITY: 2 SEVERITY: 4 RISK INDEX: 8 RESIDUAL RISK EVALUATION: AFAP NEW HAZARDS: NONE MITIGATION(S) SUFFICIENT ¿YES ¿NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOGGED VALVE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO A CLOGGED VALVE. THE FSE STARTED BY REPLACING THE VALVES TO RESOLVE THE LEAKAGE ISSUE. THEY THEN REPLACED THE FLUIDICS HARNESS TO PASS INSTRUMENT SPECIFICATIONS. AFTER RESOLVING THESE ISSUES, THE FSE REPLACED THE HALF SHELL FILTER, SHEATH FILTER, AND PERISTALTIC TUBING AS A PREVENTATIVE MAINTENANCE MEASURE. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE LEAKAGE. THE SAFETY RISK IS LIMITED, S2, AND THERE WAS NO IMPACT TO CUSTOMER HEALTH OR SAFETY.

Description of Event or Problem

IT WAS REPORTED THAT BD ACCURI¿ IS LEAKING WASTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE . 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. 3. WAS THERE SPRAY OF LIQUID? NO. 6. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. CUSTOMER REPORTS THAT THE LEAK IS COMING FROM THE BOTTOM OF THE CLEANING CYCLE - ONE OF THE RED TUBINGS FROM THE PARASTOLIC PUMP HAD POPPED OFF"

Additional Manufacturer Narrative

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 BD ACCURI¿ IS LEAKING WASTE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE. 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. WAS THERE SPRAY OF LIQUID? NO. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. CUSTOMER REPORTS THAT THE LEAK IS COMING FROM THE BOTTOM OF THE CLEANING CYCLE - ONE OF THE RED TUBINGS FROM THE PARASTOLIC PUMP HAD POPPED OFF."