BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. IT WAS REPORTED BY THE CUSTOMER INSTRUMENT LEAKING IN TWO DIFFERENT LOCATIONS. "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?" SHEATH AND WASTE FLUID. "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

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER INSTRUMENT LEAKING IN TWO DIFFERENT LOCATIONS WAS THERE A FLUIDIC LEAK OR SPILL? YES 1.WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO 2. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO 3. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES 4. WHAT WAS THE FLUID THAT LEAKED/SPILLED? SHEATH AND WASTE FLUID 5. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) UNKNOWN 6. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO 7. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO.

Additional Manufacturer Narrative

H.6: INVESTIGATION SUMMARY: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: INSTRUMENT LEAKING IN TWO DIFFERENT LOCATIONS MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 15JUN2021 TO DATE 15JUN2022 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 13 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 15JUN2021 TO DATE 15JUN2022 (ROLLING 12 MONTHS) INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: INSPECTED SYSTEM AND FOUND CRACKED FITTING. REPLACED FITTING. PREFORMED SYSTEM OPERATIONAL CHECKS. UNIT FUNCTIONING NORMALLY. RETURNED UNIT TO CUSTOMER FOR USE. O SAMPLE PREPARATION WAS NOT AFFECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: 25SEP2019 DEFECTIVE PART NUMBER: 334453 ¿ CPC ELBOW COUPLING WORK ORDER NOTES: SUBJECT / REPORTED: INSTRUMENT LEAKING IN TWO DIFFERENT LOCATIONS PROBLEM DESCRIPTION: FLUID LEAK CAUSE: CRACKED/DAMAGED FITTING WORK PERFORMED: REPLACED FITTING SOLUTION: REPLACED FITTING RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DAMAGED 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 #100245RA, REVISION 03 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:_AFAP_____ MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A CRACKED/DAMAGED FITTING CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR INSTRUMENT LEAKING. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY. H3 OTHER TEXT : SEE H.10.