BD FACS¿ SAMPLE PREP ASSISTANT

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT THE WASH TOWER LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER WAS OVERFLOWING. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT WAS LEAKED? "WASH FLUID". WHAT IS THE SOURCE OF LEAK? WASTE LINE OR NON-WASTE LINE? WASH TOWER 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. WAS THERE SPRAY OR FLUID UNDER PRESSURE? NO.

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.

Additional Manufacturer Narrative

H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 650686 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION IS OVERFLOWING. MANUFACTURING DEFECT TREND: THERE ARE (B)(4) QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 29NOV2020 TO DATE 29NOV2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE (B)(4) COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 29NOV2020 TO DATE 29NOV2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACED WASH EVACUATION PUMP WITH A NEW COMPONENT, ENSURE ALL FITTINGS ARE SECURED AND THAT THE STRAINER IS CLEAR. NO OVERFLOW OBSERVED DURING REPEATED PRIME CYCLES. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(6) 2005. DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH ASSEMBLY. WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION IS OVERFLOWING. PROBLEM DESCRIPTION: WASH STATION IS OVERFLOWING. CAUSE: WASH PUMP NOT WORKING. WORK PERFORMED: REPLACED WASH STATION PUMP. SOLUTION: REPLACED WASH STATION PUMP. RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PUMP. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN650686 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 REPORT THE ROOT CAUSE WAS A DEFECTIVE WASTE PUMP. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT THE WASH TOWER LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER WAS OVERFLOWING. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WHAT WAS THE FLUID THAT WAS LEAKED? "WASH FLUID". 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASH TOWER . 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. 7. WAS THERE SPRAY OR FLUID UNDER PRESSURE NO.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT THE WASH TOWER LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH TOWER WAS OVERFLOWING. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES 3. WHAT WAS THE FLUID THAT WAS LEAKED? "WASH FLUID" 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASH TOWER 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO 7. WAS THERE SPRAY OR FLUID UNDER PRESSURE NO

Additional Manufacturer Narrative

H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 650686 SPAIII AND SERIAL NUMBER: (B)(4) ¿ PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION 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) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS) ¿ COMPLAINT TREND: THERE ARE 3 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2020 TO DATE (B)(6) 2021 (ROLLING 12 MONTHS) O (B)(4) (THIS COMPLAINT) ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACED WASH EVACUATION PUMP WITH A NEW COMPONENT, ENSURE ALL FITTINGS ARE SECURED AND THAT THE STRAINER IS CLEAR. NO OVERFLOW OBSERVED DURING REPEATED PRIME CYCLES. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02223464 INSTALL DATE: 21APR2005 DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH ASSEMBLY WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION IS OVERFLOWING O PROBLEM DESCRIPTION: WASH STATION IS OVERFLOWING O CAUSE: WASH PUMP NOT WORKING O WORK PERFORMED: REPLACED WASH STATION PUMP O SOLUTION: REPLACED WASH STATION PUMP ¿ RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PUMP ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ RISK ANALYSIS: O RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES NO ¿ HAZARD ID: 3.1.29 _ ¿ HAZARD: ENVIRONMENTAL BIOHAZARD ¿ SEVERITY: 5 ¿ PROBABILITY: 1 ¿ RISK INDEX: 5 O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__ O RISK CONTROL:_ALARP_____ O MITIGATION(S) SUFFICIENT YES NO ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A DEFECTIVE WASTE PUMP ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW H3 OTHER TEXT : SEE H.10