BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED AND WAS NOT CONTAINED TO INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THE WASH STATION IS OVERFLOWING. SHE HAS CHECKED THE INLINE FILTER AND IT IS CLEAN, SHE TRIED FLUSHING THE LINES AS WELL, BUT THAT DID NOT CORRECT THE PROBLEM. THE INSTRUMENT IS DOWN AND OUT OF SERVICE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THE CUSTOMER REPORTS THAT THE WASH STATION IS OVERFLOWING. SHE HAS CHECKED THE INLINE FILTER AND IT IS CLEAN, SHE TRIED FLUSHING THE LINES AS WELL, BUT THAT DID NOT CORRECT THE PROBLEM. THE INSTRUMENT IS DOWN AND OUT OF SERVICE. NEXT STEPS (IF NECESSARY): DISPATCHING THE CALL. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? NO. SOFTWARE VERSION? NA. LIST OF PARTS SHIPPED (INCLUDE FOC): NA. RMA REQUIRED? NA. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? UNKNOWN. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) UNKNOWN. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. ADDITIONALLY, ON 2020-06-16 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER RUNS BLOOD SAMPLES SO I ASSUME IT WAS BLOOD MIXED WITH PROBE RINSE FLUID. IT WOULD NOT HAVE BEEN UNDER PRESSURE. THIS LEAK WOULD BE BEFORE THE WASTE TANK. IT WOULD NOT HAVE BEEN MIXED WITH ANY DECONTAMINATING AGENT AT THIS POINT IN THE SEQUENCE. THE CUSTOMER WOULD HAVE BEEN IN CONTACT WITH THE FLUID WHEN CLEANING UP THE OVERFLOWED FLUIDS. WHICH PART OF THE BODY WAS IN CONTACT TO THE FLUID? THEY WOULD HAVE USED THEIR HANDS TO CLEAN THE UP THE FLUIDS. WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS BEING WORN? THEY ALWAYS WEAR LAB COATS, GLOVES, AND FACE SHIELDS IN THE LAB WAS CUSTOMER HARMED/INJURED? (IF YES, PROVIDE DETAILS - HOW AND TO WHAT EXTENT? NO, THE CUSTOMER WAS NOT HARMED.

Additional Manufacturer Narrative

SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED THAT THE SPA 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 (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 4 OF COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE FSE REPORT VERIFIED NO ISSUE WITH WASTE LINE/FILTER. FOUND THE WASTE PUMP NEEDED TO BE CLEANED. RAN NUMEROUS PRIME FUNCTIONS WITHOUT THE WASH STATION OVERFLOWING. SYSTEM PASSED ALL REQUIRED TESTS. CUSTOMER RAN A SAMPLE TO VERIFY PROPER FUNCTION ¿ PASSED. 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: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION OVERFLOWING. PROBLEM DESCRIPTION: WASH STATION WAS OVERFLOWING. CAUSE: WASTE PUMP CLOGGED. WORK PERFORMED: CLEANED THE WASTE PUMP. SOLUTION: CLEANED THE WASTE PUMP. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. . FSE RESOLVED THE ISSUE BY CLEARING DEBRIS FROM THE WASTE PUMP ORIFICES. ALSO PARTS WERE REPLACED 640520 AND 645021. 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: RISK MANAGEMENT FILE PART #100245RA, REVISION 02 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES OR NO. HAZARD ID: (B)(4). HAZARD: ENVIRONMENTAL BIOHAZARD. SEVERITY: 5. PROBABILITY: 1. RISK INDEX: 5. IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE. RISK CONTROL: ALARP. MITIGATION(S) SUFFICIENT: YES OR NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS THE WASTE PUMP WAS CLOGGED CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED.

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. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT WASTE LEAKAGE OCCURRED AND WAS NOT CONTAINED TO INSTRUMENT WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THE WASH STATION IS OVERFLOWING. SHE HAS CHECKED THE INLINE FILTER AND IT IS CLEAN, SHE TRIED FLUSHING THE LINES AS WELL, BUT THAT DID NOT CORRECT THE PROBLEM. THE INSTRUMENT IS DOWN AND OUT OF SERVICE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THE CUSTOMER REPORTS THAT THE WASH STATION IS OVERFLOWING. SHE HAS CHECKED THE INLINE FILTER AND IT IS CLEAN, SHE TRIED FLUSHING THE LINES AS WELL, BUT THAT DID NOT CORRECT THE PROBLEM. THE INSTRUMENT IS DOWN AND OUT OF SERVICE. NEXT STEPS (IF NECESSARY): DISPATCHING THE CALL. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? NO. SOFTWARE VERSION? NA. LIST OF PARTS SHIPPED (INCLUDE FOC): NA. RMA REQUIRED? NA. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? UNKNOWN WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) UNKNOWN. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. ADDITIONALLY, ON 2020-06-16 THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CUSTOMER RUNS BLOOD SAMPLES SO I ASSUME IT WAS BLOOD MIXED WITH PROBE RINSE FLUID. IT WOULD NOT HAVE BEEN UNDER PRESSURE. THIS LEAK WOULD BE BEFORE THE WASTE TANK. IT WOULD NOT HAVE BEEN MIXED WITH ANY DECONTAMINATING AGENT AT THIS POINT IN THE SEQUENCE. THE CUSTOMER WOULD HAVE BEEN IN CONTACT WITH THE FLUID WHEN CLEANING UP THE OVERFLOWED FLUIDS. WHICH PART OF THE BODY WAS IN CONTACT TO THE FLUID? THEY WOULD HAVE USED THEIR HANDS TO CLEAN THE UP THE FLUIDS. WHAT PERSONAL PROTECTIVE EQUIPMENT (PPE) WAS BEING WORN? THEY ALWAYS WEAR LAB COATS, GLOVES, AND FACE SHIELDS IN THE LAB. WAS CUSTOMER HARMED/INJURED? (IF YES, PROVIDE DETAILS - HOW AND TO WHAT EXTENT? NO, THE CUSTOMER WAS NOT HARMED.