BD ACCURI¿

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD ACCURI¿ LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTS THAT THE INSTRUMENT LEAKS FROM THE BACK RIGHT CORNER. HE CANNOT SEE THE ORIGIN OF THE LEAKAGE. YESTERDAY, ONE OF THE WASTE TUBINGS NEXT TO THE FLOW CELL CAME LOOSE. THE CUSTOMER TRIMMED THE TUBING AND PLUGGED IT BACK IN, WHICH STOPPED THE LEAKAGE FROM THAT SIDE. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THERE SPRAY OF LIQUID? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO."

Additional Manufacturer Narrative

THE EVENT DESCRIBED OCCURRED ON AN CE-IVD INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD ACCURI¿ LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER REPORTS THAT THE INSTRUMENT LEAKS FROM THE BACK RIGHT CORNER. HE CANNOT SEE THE ORIGIN OF THE LEAKAGE. YESTERDAY, ONE OF THE WASTE TUBINGS NEXT TO THE FLOW CELL CAME LOOSE. THE CUSTOMER TRIMMED THE TUBING AND PLUGGED IT BACK IN, WHICH STOPPED THE LEAKAGE FROM THAT SIDE. ¿ WAS THE LEAK LIQUID OR AIR? LIQUID. ¿ WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. ¿ WAS THERE SPRAY OF LIQUID? NO. ¿ WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. ¿ DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN. ¿ WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. ¿ WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO."

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD ACCURI C6 PLUS, PART # 660517, AND SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING LEAKAGE NOT CONTAINED WITHIN INSTRUMENT. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 14JUN2021 TO 14JUN2022. ¿ COMPLAINT TREND: THERE ARE 6 COMPLAINTS RELATED TO THE ABOVE PROBLEM; DATE RANGE FROM 14JUN2021 TO 14JUN2022. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #660517 SERIAL # (B)(6), FILE # (B)(4), 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 LEAK WAS DUE TO A LOOSE WASTE LINE TUBING. THE CUSTOMER REPORTED THAT THE INSTRUMENT WAS LEAKING FROM THE BACK RIGHT CORNER HOWEVER, THEY COULD NOT SEE THE ORIGIN OF THE LEAKAGE. THE CUSTOMER NOTICED THAT ONE OF THE WASTE TUBING NEAR THE FLOW CELL CAME LOOSE. THEY THEN TRIMMED THE TUBING AND PLUGGED IT BACK IN WHICH CREATED A BETTER SEAL AND STOPPED THE LEAKAGE FROM THAT SIDE. THE FIELD SERVICE REPRESENTATIVE (FSR) WORKED ON THE INSTRUMENT OFF-SITE TO FIND THE ROOT CAUSE OF THE LEAK. THE FSR CREATED A WO (02510197), PERFORMED PREVENTIVE MAINTENANCE AND ANY OTHER NECESSARY REPAIRS. AFTER THE EVALUATION, THE FSR CONFIRMED THAT THE LEAK WAS ALREADY RESOLVED BY THE CUSTOMER BY RECONNECTING THE WASTE LINE TUBING BECAUSE NO FURTHER LEAKS WERE FOUND. THE REPAIRED INSTRUMENT WAS THEN SHIPPED BACK TO THE CUSTOMER AND WAS WORKING AS INTENDED. THE CUSTOMER CONFIRMED THAT THEY DID NOT COME IN PHYSICAL CONTACT WITH THE FLUID. NO PATIENT WAS HARMED OR AFFECTED. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD ACCURI C6¿ PLUS SYSTEM # 23-18013-01, REV. 01 /VERS. A PAGE 193 THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #:(B)(4). INSTALL DATE: 3JAN2018 DEFECTIVE PART NUMBER: N/A (SOME PARTS WERE REPLACED NOT RELATED TO THE LEAK, BUT FOR PREVENTIVE MAINTENANCE OR OTHER REPAIRS). WORK ORDER NOTES: O SUBJECT / REPORTED: 660517 - BD ACCURI C6 PLUS - LEAKAGE FROM BACK RIGHT OF THE INSTRUMENT. O PROBLEM DESCRIPTION: THE CUSTOMER REPORTS THAT THE INSTRUMENT LEAKS FROM THE BACK RIGHT CORNER. HE CANNOT SEE THE ORIGIN OF THE LEAKAGE. YESTERDAY, ONE OF THE WASTE TUBINGS NEXT TO THE FLOW CELL CAME LOOSE. THE CUSTOMER TRIMMED THE TUBING AND PLUGGED IT BACK IN, WHICH STOPPED THE LEAKAGE FROM THAT SIDE. O WORK PERFORMED: STANDARD DID: - PERFORMED PM: REPLACED PUMP TUBING¿S (2X 653146) AND INLINE-SHEATH FILTER (3X 653148) (STANDARD PROCEDURE). - INSTALLED BLEACH RESISTANT WASTE BOTTLE CONNECTOR (FLOORSTOCK) (UPGRADE) - CLEANED BOTTLES (STANDARD PROCEDURE). - CLEANED TUBING¿S WITH HOT WATER. - CLEANED FLUIDIC HARNESS WITH HOT WATER. - REPLACED T FITTING AND TUBING¿S AT PRESSURE SENSOR (FLOORSTOCK). - REPLACED O-RINGS SIP (FLOORSTOCK) (STANDARD PROCEDURE). - PERFORMED FLUIDIC CALIBRATION. - ADJUST CALIBRATION FACTORS. - ADJUST SOV VALUES. - TESTED BOTTLES AND REPLACED BOTTLE FILTERS (FROM FLOORSTOCK). O CAUSE: NO PEAK DETECTED. LEAK WAS ALREADY RESOLVED BY CUSTOMER, SEE DESCRIPTION. O SOLUTION: THIS INSTRUMENT IS REPAIRED AND WORKING ACCORDING BD SERVICE SPECIFICATIONS. SPARE PART ORDER NUMBER LOTS: TO2 B11728704. LABOR HOURS: 10H. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE NO PARTS WERE REPLACED FOR THE LEAK ISSUE. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART #: 10000214703, REV. 01/VERS. A, BD ACCURI C6 PLUS SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES NO. O ID: 2.1.8 O HAZARD EVENT: EXPOSURE TO BIO-HAZARDOUS MATERIAL DURING PREVENTATIVE MAINTENANCE. O CAUSE OF EVENT: USER FORGETS TO INSTALL WASTE LINE (AFTER EMPTYING WASTE BOTTLE) AND SPILLS SAMPLE WASTE FLUID DURING STARTUP. O HARMFUL EFFECTS: EXPOSURE TO BIO HAZARDOUS MATERIAL. O RISK CONTROL:. - PCYT-648 ¿ LABELING BIOHAZARD. - PCYT-2908 ¿ LABELING WASTE BOTTLE BIOHAZARD. - PCYT-3385 ¿ BIOHAZARD FLUID CONTAINMENT . - 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. O IMPLEMENTATION VERIFICATION: - MPI 7100279 ¿ MPI, ASSY., CASE, C6. - 23-18014-00 BD ACCURI¿ C6 PLUS SAFETY AND LIMITATIONS. - DRAWING ¿ 659605- ASSY, 2000ML BOTTLE FACSVIA WASTE. - 659608 ASSEMBLY, LEVEL SENSOR MANIFOLD W/ MALE . - 659605 ASSEMBLY, 2000ML FACSVIA WASTE. - 659606 FLUIDICS HARNESS WITH SHUT OFF VALVES . - SEE PCYT-648. O EFFECTIVENESS VERIFICATION: SAME AS IMPLEMENTATION VERIFICATION. O PROBABILITY: 1. O SEVERITY: 4. O RISK INDEX: 4. O RESIDUAL RISK EVALUATION: A. O NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT YES NO. ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE WAS DUE TO A LOOSE WASTE TUBING. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE ROOT CAUSE OF THE LEAK WAS A LOOSE WASTE TUBING. THE FSR CONFIRMED THAT THE ISSUE WAS RESOLVED. NO ONE WAS HARMED OR INJURED. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL..