BD FACS SPA III

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 OVERFLOWING. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 26AUG2020 TO DATE 26AUG2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 7 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 26AUG2020 TO DATE 26AUG2021 (ROLLING 12 MONTHS). INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACED THE MINIWASH PUMP (BD PART# 334297). RAN ACCURACY AND PRECISION TEST; PASSED. AFTER REPLACING THE MINIWASH PUMP THE WASH TOWER IS NO LONGER OVERFLOWING DURING USE. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: 28OCT2008; DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH ASSEMBLY. WORK ORDER NOTES: SUBJECT / REPORTED: WASH STATION OVERFLOWING; PROBLEM DESCRIPTION: WASH STATION DOES NOT DRAIN; CAUSE: CLOGGED WASTE PUMP; WORK PERFORMED: REPLACED MINIWASH ASSEMBLY; SOLUTION: REPLACED MINIWASH ASSEMBLY. 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 #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 STATION PUMP. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOWING H3 OTHER TEXT : SEE H10.

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: LEAK CHECKLIST FROM WO. 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? BEFORE WASTE LINE. 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? YES. IT WAS REPORTED THAT THE WASH TOWER IS OVERFLOWING. PROBLEM STATEMENT: WASH TOWER OVER FLOWING. ARE YOU USING THIS FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS / SUSPECT RESULTS FLAGGED BEFORE TREATING A PATIENT? NO. ERRONEOUS /SUSPECT RESULTS REPORTED? NO. PATIENT(S) TREATED? NO. SOFTWARE VERSION? UNKNOWN. LEAK (IF YES EXPLAIN)? YES. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? YES. 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 LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? YES. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. WAS THE FLUID SPRAYING OUT FROM THE POINT OF THE LEAK? NO. WAS THE WASTE MIXED WITH DECONTAMINATION / BLEACH SOLUTION? NO. WAS PROPER PPE BEING WORN AT TIME OF LEAK AND DURING CLEAN UP? YES.

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: LEAK CHECKLIST FROM WO: 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? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? YES. IT WAS REPORTED THAT THE WASH TOWER IS OVERFLOWING. PROBLEM STATEMENT: WASH TOWER OVER FLOWING ARE YOU USING THIS FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS / SUSPECT RESULTS FLAGGED BEFORE TREATING A PATIENT? NO. ERRONEOUS /SUSPECT RESULTS REPORTED? NO. PATIENT(S) TREATED? NO. SOFTWARE VERSION? UNKNOWN. LEAK (IF YES EXPLAIN)? YES. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? YES. 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 LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? YES. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. WAS THE FLUID SPRAYING OUT FROM THE POINT OF THE LEAK? NO. WAS THE WASTE MIXED WITH DECONTAMINATION / BLEACH SOLUTION? NO. WAS PROPER PPE BEING WORN AT TIME OF LEAK AND DURING CLEAN UP? YES.