BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE RUNNING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF PATIENT/USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WASH STATION IS OVER FLOWING. THEY CLEANED THE INLINE FILTER AND ALL TUBES WHICH DID NOT HELP. IT IS OVERFLOWING ON THE INITIALIZATION AND DURING A RUN."

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 OVERFLOWING. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 25AUG2020 TO DATE 25AUG2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 24 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 25AUG2020 TO DATE 25AUG2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPAIR/TROUBLESHOOTING PERFORMED: CLEARED THE CLOG FROM THE WASH PUMP. FLUSHED THE WASTE FILTER FITTINGS AND TUBING. RAN MULTIPLE FLUIDIC PRIMES TO VERIFY OPERATION. THE WASH STATION IS NOW PROPERLY EMPTIED AND IS NOT OVERFLOWING. THE INSTRUMENT IS OPERATING AS INTENDED AND IS TESTING WITHOUT ERRORS. RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: 01JUL2010. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION OVERFLOW, PROBLEM DESCRIPTION: WASH STATION OVERFLOW, CAUSE: CLOGGED WASH PUMP AND FILTERS, WORK PERFORMED: CLEANED CLOGGED WASH PUMP AND FILTERS, SOLUTION: CLEANED CLOGGED WASH PUMP AND FILTERS. 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/ NO, HAZARD ID: 3.1.29 _, 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/ NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S COMMENTS THE ROOT CAUSE WAS CLOGGED WASH PUMP AND FILTERS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW.

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. MEDICAL DEVICE EXPIRATION DATE: NA.

Description of Event or Problem

IT WAS REPORTED THAT WHILE RUNNING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF PATIENT/USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " WASH STATION IS OVER FLOWING. THEY CLEANED THE INLINE FILTER AND ALL TUBES WHICH DID NOT HELP. IT IS OVERFLOWING ON THE INITIALIZATION AND DURING A RUN."