BD FACS SPA III

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SPA III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. 4. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. 6. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. 7. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. IT WAS REPORTED THAT THE WASH STATION DOES NOT DRAIN. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: WASH STATION DOES NOT DRAIN. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THEY HAVE CHECKED THE FILTER AND EVEN BYPASSED IT BUT THIS DID NOT HELP. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? NO. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. LEAK (IF YES EXPLAIN)? YES. RESOLUTION ACHIEVED (Y/N)? NO. FOLLOW UP REQUIRED (Y/N)? YES. LIST OF PARTS SHIPPED (INCLUDE FOC): N/A. RMA REQUIRED (Y/N)? N/A.

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 DOES NOT DRAIN. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 30JUL2020 TO DATE 30JUL2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 16 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 30JUL2020 TO DATE 30JUL2021 (ROLLING 12 MONTHS) . INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPAIR/TROUBLESHOOTING PERFORMED: REPLACED WASH PUMP AND INLINE FILTER. INSTRUMENT IS PERFORMING AS REQUIRED. NO ONE WAS EXPOSED TO ANY BIO-HAZARDOUS MATERIAL. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(6). DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH ASSEMBLY / 640835 ¿ SPA INLINE FILTER KIT WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION DOES NOT DRAIN. PROBLEM DESCRIPTION: WASH STATION DOES NOT DRAIN. CAUSE: CLOGGED WASH PUMP AND FILTERS. WORK PERFORMED: REPLACED MINIWASH ASSEMBLY AND FILTERS. SOLUTION: REPLACED MINIWASH ASSEMBLY AND FILTERS . RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF 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 AND THE FSE¿S COMMENTS THE ROOT CAUSE WAS CLOGGED WASH PUMP AND FILTERS. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION DOES NOT DRAIN.

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.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SPA III BIOHAZARDOUS WASTE LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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? BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. IT WAS REPORTED THAT THE WASH STATION DOES NOT DRAIN. IS INSTRUMENT ASSURITY LINC ENABLED? N CUSTOMER PROBLEM: WASH STATION DOES NOT DRAIN STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THEY HAVE CHECKED THE FILTER AND EVEN BYPASSED IT BUT THIS DID NOT HELP. NEXT STEPS (IF NECESSARY): DISPATCH ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? N WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N WAS THERE ANY INJURY OR POTENTIAL INJURY? N LEAK (IF YES EXPLAIN)? Y RESOLUTION ACHIEVED (Y/N)? N FOLLOW UP REQUIRED (Y/N)? Y LIST OF PARTS SHIPPED (INCLUDE FOC): N/A RMA REQUIRED (Y/N)? N/A