BD FACS¿ SPA III

Description of Event or Problem

IT WAS REPORTED THAT THE BD FACS¿ SPA III LEAKED BIOHAZARD WASTE LIQUID OUTSIDE THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WASH STATION OVER FLOWING. THEY WERE ABLE TO DO INITIALIZATION WHICH PASSED BUT THEN WHEN THEY WENT TO RUN SAMPLES THE WASH STATION STARTED OVERFLOWING." "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" "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? UNKNOWN 5) DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO".

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 11AUG2020 TO DATE 11AUG2021 (ROLLING 12 MONTHS). COMPLAINT TREND: THERE ARE 9 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 11AUG2020 TO DATE 11AUG2021 (ROLLING 12 MONTHS) . INVESTIGATION RESULT / ANALYSIS: CUSTOMER PROBLEM: WASH STATION OVERFLOWING. O STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER WAS ABLE TO DO INITIALIZATION WHICH PASSED BUT THEN WHEN THEY WENT TO RUN SAMPLES THE WASH STATION STARTED OVERFLOWING. ASKED CUSTOMER TO CLEAN THE IN-LINE FILTER. CLEANING THE INLINE FILTER SEEMS TO HAVE FIXED THE ISSUE. CUSTOMER ASKED THAT WE LEAVE THE CASE OPEN UNTIL NEXT DAY. CUSTOMER SAID IF WE DO NOT HEAR BACK FROM THEM BY 12PM EST THE NEXT DAY WE CAN CLOSE THE CASE. CUSTOMER DID NOT CALL BACK. THIS CASE HAS BEEN CLOSED TO A PHONE FIX. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER#: NO WORK ORDER WAS ISSUED. ISSUE WAS RESOLVED BY PHONE. INSTALL DATE: 02OCT2007. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PART. WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION IS OVERFLOWING. O PROBLEM DESCRIPTION: FILTER CLOGGED. O CAUSE: CLOGGED FILTER. O WORK PERFORMED: CLEANED INLINE FILTER. O SOLUTION: CLEANED INLINE FILTER . RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND (PN337170) PN650686 DHR IS ARCHIVED. THIS IS A SPAII THAT WAS INSTALLED IN 2007 AND UPGRADED TO A SPAIII. RISK ANALYSIS: O RISK MANAGEMENT FILE PART #(B)(4), REVISION 02 WAS REVIEWED. O HAZARD(S) IDENTIFIED? YES NO. ¿ HAZARD ID: 3.1.29 _. ¿ HAZARD: ENVIRONMENTAL BIOHAZARD. ¿ SEVERITY: 5. ¿ PROBABILITY: 1. ¿ RISK INDEX: 5. O IMPLEMENTATION: BD FACS SAMPLE PREP USER¿S GUIDE__. O RISK CONTROL:_ALARP_____. O MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S COMMENTS THE ROOT CAUSE WAS CLOGGED WASH PUMP . CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION DOES NOT DRAIN.

Description of Event or Problem

IT WAS REPORTED THAT THE BD FACS¿ SPA III LEAKED BIOHAZARD WASTE LIQUID OUTSIDE THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WASH STATION OVER FLOWING. THEY WERE ABLE TO DO INITIALIZATION WHICH PASSED BUT THEN WHEN THEY WENT TO RUN SAMPLES THE WASH STATION STARTED OVERFLOWING." "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." " 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? UNKNOWN. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? BEFORE WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? 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: NA. DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON 2021-08-11. AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON 2021-11-22 THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.