BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: LIQUID ESCAPES FROM THE WASHING STATION. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? DI WATER MIXED WITH BLOOD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED: PROBLEM WITH THE WASH STATION. MANUFACTURING DEFECT TREND: THERE ARE (B)(4) 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 9 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). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: FOUND PLASTIC PARTICLES CLOGGING IN LINE FILTER CONNECTORS IN FRONT OF THE WASTE PUMP. FILTER REMOVED AND CLEANED. CONNECTORS ON THE FILTER OF THE WASTE PUMP REPLACED. REPEATED PRIME OF THE SYSTEM (FLOW, LYSE, DI WATER). DAILY CLEAN CARRIED OUT. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(6) 2013. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: PROBLEM WITH THE WASH STATION. PROBLEM DESCRIPTION: WASH STATION DOES NOT DRAIN. CAUSE: CLOGGED WASTE PUMP FILTER AND CONNECTORS. WORK PERFORMED: CLEANED FILTER AND REPLACED CONNECTORS. SOLUTION: CLEANED FILTER AND REPLACED CONNECTORS. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND PN647205 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 FILTER AND CONNECTORS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE PROBLEM WITH THE WASH STATION.

Description of Event or Problem

IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: LIQUID ESCAPES FROM THE WASHING STATION. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? DI WATER MIXED WITH BLOOD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

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.