BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: X0011 PROBLEM STATEMENT: CUSTOMER REPORTED THAT THE TUBING COMING FROM THE WASH TOWER NEEDS TO BE REPLACED, WASH TOWER IS OVERFLOWING MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 06MAY2019 TO DATE 06MAY2020 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE IS 1 OF COMPLAINT RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 06MAY2019 TO DATE 06MAY2020 (ROLLING 12 MONTHS) RELATED COMPLAINT: THIS COMPLAINT INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE FSE REPORT THE WASTE FILTER WAS INCORRECTLY ASSEMBLED BY THE CUSTOMER WHICH CAUSED THE WASH TOWER TO OVERFLOW. FSE CLEANED AND REASSEMBLED THE WASTE FILTER. SYSTEM PASSED ALL REQUIRED TESTS. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER (B)(4). INSTALL DATE: (B)(6) 2009. DEFECTIVE PART NUMBER:NO DEFECTIVE PARTS. WORK ORDER NOTES: O SUBJECT / REPORTED: WASH TOWER TUBING NEEDED TO BE REPLACED. O PROBLEM DESCRIPTION: WASH TOWER WAS OVERFLOWING. O CAUSE: FILTER WAS INCORRECTLY ASSEMBLED BY THE CUSTOMER. O WORK PERFORMED: RE-ASSEMBLED WASH TOWER FILTER. O SOLUTION: RE-ASSEMBLE THE WASH TOWER FILTER. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. THE ISSUE WAS RESOLVED ON WORK ORDER (B)(4) BY CLEANING AND RE-BUILDING THE WASTE FILTER. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR PN 647205 FOR SERIAL NUMBER: X0011 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? X YES NO. IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN? 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: DESIGN - SPILL CONTAINMENT ON WORKTABLE. MITIGATION(S) SUFFICIENT: X YES NO. IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, PER FSE THE ROOT CAUSE WAS THE WASTE FILTER WAS INCORRECTLY ASSEMBLED BY THE CUSTOMER. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, FSE CONFIRMED THE FAILURE. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED THAT WAS NOT CONTAINED WITHIN INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBING COMING FROM WASH TOWER NEEDS TO BE REPLACED, WASH TOWER IS OVERFLOWING. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES EXPLAIN)? Y, WASH TOWER OVERFLOWING. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? Y. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? Y. 3. WHAT WAS THE FLUID THAT LEAKED? WASTE 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED (Y/N)? N/A . ADDITIONALLY, ON 2020-05-14 THE BD FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THE CUSTOMER IN CONTACT WITH THE OVERFLOW OF WASTE? YES, THEY CLEANED IT UP AND THEY WERE THE REASON THE WASTE OVERFLOWED BY NOT RE-BUILDING THE WASTE FILTER CORRECTLY. WAS THE WASTE MIXED WITH BLEACH OR A DECONTAMINATE? UNKNOWN, I'M SURE LABCORP EMPLOYEE CLEAN IT USING LABCORP RULES ON WASTE SPILLS. DID THE CUSTOMER'S CLOTHING OR SKIN COME IN CONTACT WITH THE WASTE? NO. DID THEY INHALE ANY OF THE WASTE? NO. ADDITIONALLY, ON 2020-05-29 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: - WASTE LEAK (WASH TOWER WAS OVERFLOWING) - WAS NOT CONTAINED WITHIN THE INSTRUMENT. - IT WAS FROM AN IN-LINE FILTER *BEFORE* THE WASTE TANK (NO DECONTAMINATE/BLEACH) - CUSTOMER'S CLOTHING/SKIN DID NOT COME IN CONTACT WITH THE WASTE. - CUSTOMER DID NOT INHALE ANY OF THE WASTE.

Additional Manufacturer Narrative

(B)(4). 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 WASTE LEAKAGE OCCURRED THAT WAS NOT CONTAINED WITHIN INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBING COMING FROM WASH TOWER NEEDS TO BE REPLACED, WASH TOWER IS OVERFLOWING. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N WAS THERE ANY INJURY OR POTENTIAL INJURY? N LEAK (IF YES EXPLAIN)? Y, WASH TOWER OVERFLOWING WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? Y WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? Y 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? N WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK, N SOFTWARE VERSION? UNKNOWN RESOLUTION ACHIEVED (Y/N)? N FOLLOW UP REQUIRED (Y/N)? Y LIST OF PARTS SHIPPED (INCLUDE FOC): N/A RMA REQUIRED (Y/N)? N/A ADDITIONALLY, ON 2020-05-14 THE BD FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WAS THE CUSTOMER IN CONTACT WITH THE OVERFLOW OF WASTE? YES, THEY CLEANED IT UP AND THEY WERE THE REASON THE WASTE OVERFLOWED BY NOT RE-BUILDING THE WASTE FILTER CORRECTLY. WAS THE WASTE MIXED WITH BLEACH OR A DECONTAMINATE? UNKNOWN, I'M SURE LABCORP EMPLOYEE CLEAN IT USING LABCORP RULES ON WASTE SPILLS DID THE CUSTOMER'S CLOTHING OR SKIN COME IN CONTACT WITH THE WASTE? NO DID THEY INHALE ANY OF THE WASTE? NO ADDITIONALLY, ON 2020-05-29 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WASTE LEAK (WASH TOWER WAS OVERFLOWING) WAS NOT CONTAINED WITHIN THE INSTRUMENT IT WAS FROM AN IN-LINE FILTER *BEFORE* THE WASTE TANK (NO DECONTAMINATE/BLEACH) CUSTOMER'S CLOTHING/SKIN DID NOT COME IN CONTACT WITH THE WASTE CUSTOMER DID NOT INHALE ANY OF THE WASTE