BD FACS SAMPLE PREP ASSISTANT III

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: SYSTEM IS LEAKING FLUID. ¿ MANUFACTURING DEFECT TREND: THERE ARE (B)(4) QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 29SEP2020 TO DATE 29SEP2021 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE (B)(4) COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 29SEP2020 TO DATE 29SEP2021 (ROLLING 12 MONTHS) . ¿ INVESTIGATION RESULT / ANALYSIS: PER WORK ORDER INFORMATION: CLEANED PUMP AND REPLACED MINIWASH ASSEMBLY. NO OTHER INFORMATION AVAILABLE ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(6) 2010. DEFECTIVE PART NUMBER: 334297 ¿ MINIWASH ASSEMBLY. WORK ORDER NOTES: O SUBJECT / REPORTED: SYSTEM LEAKING. O PROBLEM DESCRIPTION: WASH STATION PUMP CLOGGED. O CAUSE: CLOGGED WASH PUMP. O WORK PERFORMED: REPLACED WASH STATION PUMP. O SOLUTION: REPLACED WASH STATION PUMP. ¿ RETURNED SAMPLE EVALUATION: DID NOT REQUEST RETURN OF DEFECTIVE MATERIAL. ¿ 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: O RISK MANAGEMENT FILE PART #100245RA, 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 WORK ORDER INFORMATION THE ROOT CAUSE WAS CLOGGED WASH PUMP . ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE WORK ORDER INFORMATION THE COMPLAINT WAS CONFIRMED FOR THE LEAKING FLUIDS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SAMPLE PREP ASSISTANT III THERE WAS LEAKAGE OF BIOHAZARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SPA III HAS EXPIRED, ALREADY KNOWS (NO CASE IN THE SYSTEM) AND ORDERS A PUMP TO THEN EXCHANGE IT. LOTS OF BLOOD LEAKED FROM THE DEVICE, NOBODY HAD DIRECT CONTACT WITH IT (PPE WAS WORN).

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACS SAMPLE PREP ASSISTANT III THERE WAS LEAKAGE OF BIOHAZARD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SPA III HAS EXPIRED, ALREADY KNOWS (NO CASE IN THE SYSTEM) AND ORDERS A PUMP TO THEN EXCHANGE IT. LOTS OF BLOOD LEAKED FROM THE DEVICE, NOBODY HAD DIRECT CONTACT WITH IT (PPE WAS WORN).

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.