BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE RUNNING BD FACS SAMPLE PREP ASSISTANT III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WAS THE LEAK LIQUID OR AIR? LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO PER CASE 1. WAS THE LEAK LIQUID OR AIR? LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED 3. WAS THERE SPRAY OF LIQUID? NO THERE WAS NO SPRAY OF LIQUID 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN 6. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO 7. WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING. CUSTOMER PROBLEM: EMAIL STATES: WASH STATION OVERFLOWING STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: EMAIL STATES: WASH STATION OVERFLOWING I EMAILED THE CUSTOMER ASKING HER TO PLEASE CLEAN HER IN-LINE FILTER TO SEE IF THIS WILL RESOLVE HER ISSUE AND TO GET BACK TO US WITH THE RESULTS. ARE YOU USING THIS FOR CLINICAL DIAGNOSTIC TEST? YES WERE ERRONEOUS / SUSPECT RESULTS FLAGGED BEFORE TREATING A PATIENT? NO ERRONEOUS /SUSPECT RESULTS REPORTED? NO PATIENT(S) TREATED? NO SOFTWARE VERSION? UNKNOWN LEAK (IF YES EXPLAIN)? YES

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII 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 (B)(6) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 12 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6)2020 TO DATE (B)(6)2021 (ROLLING 12 MONTHS) INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPAIR/TROUBLESHOOTING PERFORMED: REPLACED QUICK DISCONNECT FITTINGS ON IN-LINE FILTER. CLEANED DEBRIS FROM WASH STATION AND MINI WASH PUMP. VERIFIED INSTRUMENT PERFORMANCE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4) INSTALL DATE: (B)(6) 2009 DEFECTIVE PART NUMBER: 640520 COUPLING, 640521 COUPLING WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION IS OVERFLOWING O PROBLEM DESCRIPTION: WASH STATION PUMP CLOGGED O CAUSE: CLOGGED WASH PUMP O WORK PERFORMED: CLEANED PUMP O SOLUTION: CLEANED PUMP RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PARTS MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: O RISK MANAGEMENT FILE PART #(B)(4), REVISION 02 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES NO HAZARD ID: 3.1.29 _ HAZARD: ENVIRONMENTAL BIOHAZARD SEVERITY: 5 PROBABILITY: 1 RISK INDEX: 5 O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__ O RISK CONTROL:_ALARP_____ O MITIGATION(S) SUFFICIENT YES NO ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S COMMENTS THE ROOT CAUSE WAS CLOGGED WASH PUMP. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW.

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS MEDICAL DEVICE EXPIRATION DATE: NA. 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 WHILE RUNNING BD FACS SAMPLE PREP ASSISTANT III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? BEFORE WASTE LINE -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. PER CASE 1. WAS THE LEAK LIQUID OR AIR? LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID? NO THERE WAS NO SPRAY OF LIQUID. 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN. 6. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. 7. WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING. CUSTOMER PROBLEM: EMAIL STATES: WASH STATION OVERFLOWING STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: EMAIL STATES: WASH STATION .OVERFLOWING I EMAILED THE CUSTOMER ASKING HER TO PLEASE CLEAN HER IN-LINE FILTER TO SEE IF THIS WILL RESOLVE HER ISSUE AND TO GET BACK TO US WITH THE RESULTS. ARE YOU USING THIS FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS / SUSPECT RESULTS FLAGGED BEFORE TREATING A PATIENT? NO. ERRONEOUS /SUSPECT RESULTS REPORTED? NO. PATIENT(S) TREATED? NO. SOFTWARE VERSION? UNKNOWN. LEAK (IF YES EXPLAIN)? YES.