BD FACS¿ SAMPLE PREP ASSISTANT

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS LEAK CONTAINED IN INSTRUMENT? NO. WAS LEAK IN CUSTOMER ACCESSIBLE LOCATION? YES .WHAT WAS FLUID LEAKED? SHEATH FLUID. WHAT WAS SOURCE OF LEAK? WASH TOWER. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. IT WAS REPORTED THAT WASTE TOWER OVERFLOWING".

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 337170 SPAII 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 05APR2021 TO DATE 05APR2022 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE 3 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 05APR2021 TO DATE 05APR2022. ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: FOUND: WASH TOWER OVERFLOWING - REPLACED WASTE PUMP AND INLINE FILTER. INSTRUMENT OPERATING WITHIN BD SPECIFICATIONS. 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# 02402704. INSTALL DATE: 08MAR2005 DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH ASSEMBLY, 640835 ¿ SPA INLINE FILTER KIT WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION OVERFLOWING. O PROBLEM DESCRIPTION: WASH TOWER OVERFLOWING. O CAUSE: DEFECTIVE WASTE PUMP. O WORK PERFORMED: REPLACED WASTE PUMP. O SOLUTION: REPLACED WASTE PUMP. ¿ RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PART. ¿ 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: O RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES OR NO? O HAZARD ID: 3.1.29. O HAZARD: ENVIRONMENTAL BIOHAZARD. O SEVERITY: 5. O PROBABILITY: 1. O RISK INDEX: 5. O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE: O RISK CONTROL: AFAP. O MITIGATION(S) SUFFICIENT: YES OR NO? ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A DEFECTIVE WASTE PUMP. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION TO OVERFLOW. 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.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. WAS LEAK CONTAINED IN INSTRUMENT? NO. 2. WAS LEAK IN CUSTOMER ACCESSIBLE LOCATION? YES. 3. WHAT WAS FLUID LEAKED? SHEATH FLUID. 4. WHAT WAS SOURCE OF LEAK? WASH TOWER. 5. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. IT WAS REPORTED THAT WASTE TOWER OVERFLOWING."