BD FACS SAMPLE PREP ASSISTANT III

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. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING. CUSTOMER PROBLEM: WASH STATION OVERFLOWING. IS THIS INSTRUMENT USED FOR CLINICAL TESTING? YES. LEAK QUESTIONS (IF OCCURRED). LEAK (IF YES EXPLAIN)? YES. WASH STATION OVERFLOWED. NO PRESSURE OR SPRAY. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE. 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 THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKAGE OCCURRED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING. CUSTOMER PROBLEM: WASH STATION OVERFLOWING. IS THIS INSTRUMENT USED FOR CLINICAL TESTING? YES. LEAK QUESTIONS (IF OCCURRED): LEAK (IF YES EXPLAIN)? YES. WASH STATION OVERFLOWED. NO PRESSURE OR SPRAY. 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 LEAKED? WASTE. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE. 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.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: WASH TOWER ¿ WASTE LEAKAGE. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 10DEC2019 TO DATE 10DEC2020 (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 10DEC2019 TO DATE 10DEC2020 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACED THE CLOGGED FITTINGS. PERFORMED MULTIPLE FLUID PRIMES TO ENSURE THE WASH STATION WAS BEING PROPERLY DRAINED. REPLACING THE CLOGGED FITTINGS RESOLVED THE ISSUE. THE INSTRUMENT IS OPERATING AS INTENDED AND IS TESTING WITHOUT ERRORS. THE INSTRUMENT HAS BEEN RETURNED TO THE LAB FOR NORMAL USE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #(B)(4); INSTALL DATE: (B)(6) 2009; DEFECTIVE PART NUMBER: 640521 COUPLING. WORK ORDER NOTES: SUBJECT / REPORTED: WASH TOWER LEAKAGE; PROBLEM DESCRIPTION: CLOGGED FITTING; CAUSE: CLOGGED FITTING; WORK PERFORMED: REPLACED THE CLOGGED FITTING; SOLUTION: REPLACED THE CLOGGED FITTING. RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PART. 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 #(B)(4), 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 CLOGGED FITTING. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH TOWER LEAKAGE.