BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT THE BD FACS¿ SAMPLE PREP ASSISTANT III HAS A LEAK IN WASH WELL AND BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A LEAK COMING FROM THE WASH WELL. 1. WAS THE LEAK FLUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIO HAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN? NO.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: LEAKING WASH WELL 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 24 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2020 TO DATE 1(B)(6) 2021 (ROLLING 12 MONTHS) COMPLAINT TREND DATA ATTACHED: INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: CLEARED THE CLOG FROM THE WASH PUMP. VERIFIED PROPER WASTE FLOW FROM THE WASH WELL. THE INSTRUMENT IS OPERATING AS INTENDED AND IS TESTING WITHOUT ERRORS. I HAVE RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE. NO ONE CAME IN CONTACT WITH ANY FLUIDS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #(B)(4). INSTALL DATE: 31AUG2009. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS CLOGGED. PROBLEM DESCRIPTION: WASTE LINES ARE CLOGGED. CAUSE: CLOGGED WASH STATION PUMP. WORK PERFORMED: CLEAR THE CLOGGED PUMP. SOLUTION: CLEARED THE CLOGGED PUMP. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS 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 CLOGGED WASH STATION PUMP. 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. 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 THE BD FACS¿ SAMPLE PREP ASSISTANT III HAS A LEAK IN WASH WELL AND BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. IT WAS REPORTED BY THE CUSTOMER THAT THERE IS A LEAK COMING FROM THE WASH WELL. WAS THE LEAK FLUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIO HAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION OR BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE (E.G. INHALATION), AND NON-INTACT SKIN. NO?