BD FACS SAMPLE PREP ASSISTANT

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT WASTE LEAKED OUTSIDE OF THE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH STATION OVER FLOWS AND POSSIBLE WASTE TANK OVER FLOW WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 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? WASTE. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE LINE. 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.

Description of Event or Problem

IT WAS REPORTED WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT WASTE LEAKED OUTSIDE OF THE INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH STATION OVER FLOWS AND POSSIBLE WASTE TANK OVER FLOW WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. 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? WASTE. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE LINE. 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.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY : SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 650686 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION OVERFLOWS. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 30APR2020 TO DATE 30APR2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 2 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 30APR2020 TO DATE 30APR2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: CUSTOMER CLEANED INLINE FILTER AND FITTINGS CHECKED WASTE TANK LEVEL SENSOR PROBE. THIS RESOLVED THE ISSUE. CUSTOMER HAS BEEN RUNNING SPA FOR SEVERAL DAYS WITHOUT ISSUE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER#: NO WORK ORDER WAS INITIATED. INSTALL DATE: (B)(6) 2003. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: OVERFLOWING WASH COLUMN. PROBLEM DESCRIPTION: CLOGGED FLUIDICS LINES. CAUSE: CLOGGED PUMP FILTER AND COUPLINGS. WORK PERFORMED: CLEARED FLUIDICS LINES. SOLUTION: CLEARED FLUIDICS LINES. 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 THE ROOT CAUSE WAS CLOGGED FLUIDICS LINE AND COUPLINGS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW H3 OTHER TEXT : SEE H10.