BD FACS¿ SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. 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 BD FACS¿ SAMPLE PREP ASSISTANT III WAS LEAKING BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. 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? 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? WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN: NO. IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING."

Description of Event or Problem

IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III WAS LEAKING BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. 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? 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? WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO. IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING".

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6) . PROBLEM STATEMENT: CUSTOMER REPORTED: WASH STATION IS OVERFLOWING MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 18DEC2020 TO DATE 18DEC2021 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 9 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 18DEC2020 TO DATE 18DEC2021 (ROLLING 12 MONTHS) INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACED CONNECTOR ON FILTER AND SUCCESSFULLY PRIMED SYSTEM WITH NO ISSUES. NO FURTHER INFORMATION PROVIDED SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02257449 INSTALL DATE: 01APR2012 DEFECTIVE PART NUMBER: 640521 ¿ COUPLING INSERT VALVE WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION IS OVERFLOWING O PROBLEM DESCRIPTION: WASH STATION IS OVERFLOWING O CAUSE: DAMAGED CONNECTOR O WORK PERFORMED: REPLACED FILTER CONNECTOR O SOLUTION: REPLACED FILTER CONNECTOR RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE PART MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: REVIEW OF THE DHR FOR SERIAL NUMBER: X0178 AND PN647205 WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. RISK ANALYSIS: O RISK MANAGEMENT FILE PART #100245RA, REVISION 03 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 REPORT THE ROOT CAUSE WAS A DAMAGED FILTER CONNECTOR CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR THE WASH STATION OVERFLOW H3 OTHER TEXT : SEE H10