BD FACS¿ SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT THE WASHING COLUMN OF A BD FACS¿ SAMPLE PREP ASSISTANT III LEAKED BIOHAZARDOUS WASTE OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THE WASHING COLUMN IS OVERFLOWING. THE CUSTOMER HAS CLEANED THE FILTER BUT THE PROBLEM PERSISTS. IS THE LEAK FLUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THE FLUID ACTIVELY SPRAYING ABOUT OUTSIDE THE MACHINE? NO. IS LEAKED LIQUID TYPE KNOWN? BIOHAZARDOUS OR NON-BIOHAZARDOUS? BIOHAZARD. DID THE LEAKED LIQUID HAVE BLEACH MIXED IN? NO. WAS ANYONE INJURED DUE TO THE LEAKED LIQUID? NO.

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING & 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 THE WASHING COLUMN OF A BD FACS¿ SAMPLE PREP ASSISTANT III LEAKED BIOHAZARDOUS WASTE OUTSIDE OF INSTRUMENT. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THE WASHING COLUMN IS OVERFLOWING. THE CUSTOMER HAS CLEANED THE FILTER BUT THE PROBLEM PERSISTS. 1. IS THE LEAK FLUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THE FLUID ACTIVELY SPRAYING ABOUT OUTSIDE THE MACHINE? NO. 4. IS LEAKED LIQUID TYPE KNOWN? BIOHAZARDOUS OR NON-BIOHAZARDOUS? BIOHAZARD. 5. DID THE LEAKED LIQUID HAVE BLEACH MIXED IN? NO. 6. WAS ANYONE INJURED DUE TO THE LEAKED LIQUID? NO.

Additional Manufacturer Narrative

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 OVERFLOWING MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 11FEB2021 TO DATE 11FEB2022 (ROLLING 12 MONTHS) COMPLAINT TREND: THERE ARE 14 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 11FEB2021 TO DATE 11FEB2022 (ROLLING 12 MONTHS) INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: REPLACEMENT MINI WASH PUMP WASTE # 334297 AS IT IS FAULTY. CHECK GENERAL GOOD OPERATION ACCORDING TO BD SPECIFICATIONS. CUSTOMER DID NOT COME IN CONTACT WITH ANY FLUIDS. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# (B)(4). INSTALL DATE: (B)(6) 2017. DEFECTIVE PART NUMBER: 334297¿ MINIWASH ASSEMBLY. WORK ORDER NOTES: O SUBJECT / REPORTED: WASH STATION IS OVERFLOWING. O PROBLEM DESCRIPTION: WASH STATION OVERFLOWING. O CAUSE: DEFECTIVE WASTE PUMP. O WORK PERFORMED: REPLACED WASTE PUMP. O SOLUTION: REPLACED WASTE PUMP. 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) 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. O HAZARD ID: 3.1.29 _ O HAZARD: ENVIRONMENTAL BIOHAZARD. O SEVERITY: 5. O PROBABILITY: 1. O 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 DEFECTIVE WASTE PUMP. 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.