BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING, AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III THERE WAS A BIOHAZARD LEAK. NO INQUIRES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPORTER: THE CUSTOMER REPORTED A LEAK INSIDE THE INSTRUMENT.

Description of Event or Problem

IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III THERE WAS A BIOHAZARD LEAK. NO INQUIRES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPORTER: THE CUSTOMER REPORTED A LEAK INSIDE THE INSTRUMENT.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY (B)(4) PN: 647205 SPAIII SN: (B)(6) AWARENESS: 12/08/2022 OPENED: 12/08/2022 INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6) PROBLEM STATEMENT: CUSTOMER REPORTED: SPA - LEAK. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 08DEC2021 TO DATE 08DEC2022 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 11 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 08DEC2021 TO DATE 08DEC2022 (ROLLING 12 MONTHS) COMPLAINT DATA ATTACHED. INVESTIGATION RESULT / ANALYSIS: PER FSE¿S REPORT: PERFORM 25 X SHEATH PRIME, AND MULTIPLE LYSE, DI AND DI2 PRIME WITH NO SIGN OF OVERFILLING IN WASH STATION. OPEN AND INSPECT WASTE FILTER WITH SMALL AMOUNT OF TUBE CAP DEBRIS SEEN. WASHED FILTER AND REFITTED. REPLACE 4-PORT VALVE ADAPTORS. REPLACE PROBE AND CHECK ALIGNMENT TO WASH STATION AND VERIFY REFERENCE POINT. RUN 10 SAMPLE/20 TUBE DUMMY 4CTBNK ASSAY WITH NO ISSUE SEEN. REPEAT DUMMY TEST ALL OK. OBSERVE LIVE SAMPLE PREPARATION COMPLETE ON SPA WITH GOOD RESULTS SEEN ON CANTO. ADVISE THAT DUE TO VARYING BRANDS OF SAMPLE TUBES BEING RUN ON SPA THAT THE WASTE FILTER IS OPENED AND INSPECTED FOR DEBRIS EVERY DAY AND IF OVERFILLING OF THE WASH STATION IS SEEN. INSTRUMENT RETURNED TO USER IN FULL WORKING ORDER. NO FURTHER ISSUES. 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#: WO - (B)(4). INSTALL DATE: 16MAY2014 DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: SUBJECT / REPORTED: LEAK PROBLEM DESCRIPTION: LEAK CAUSE: WASH FILTER HAD DEBRIS FROM TUBE CAPS WORK PERFORMED: WASHED FILTER SOLUTION: WASHED FILTER PARTS REPLACED: 339116 ¿ 4-WAY VALVE ADAPTERS RETURNED SAMPLE ANALYSIS: THERE WERE NO DEFECTIVE PARTS. SAMPLE RETURN WAS NOT REQUESTED. NO PARTS WERE REPLACED. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED AND NO PHOTO(S) / PICTURE(S) WERE PROVIDED MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: X0323 AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES/NO. HAZARD ID: 3.1.29. HAZARD: ENVIRONMENT BIOHAZARD. CAUSE: FILTER/COMPONENTS IN FLUID PATH GET CLOGGED, WASH STATION BACKS UP DUE TO WASTE PUMP FAILURE HARMFUL EFFECTS: EXPOSURE TO BIOHAZARD. RESIDUAL SEVERITY: 5. RESIDUAL PROBABILITY: 1. RESIDUAL RISK INDEX: 5. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND FSE¿S REPORT THE ROOT CAUSE WAS BY CLOGGED WASH STATION FILTER CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR SPA LEAK. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY.