FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD SPA BIOHAZARD LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: SPA IS LEAKING. THEY CLEANED THE IN-LINE FILTER BUT THAT DID NOT WORK. 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? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

Additional Manufacturer Narrative

AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: PN: 647205. SPAIII. SN: (B)(6). DATE REPORTED: 06/04/2022. ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED: SPA IS LEAKING. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 04JUN2021 TO DATE 04JUN2022 (ROLLING 12 MONTHS). ¿ COMPLAINT TREND: THERE ARE 13 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 04JUN2021 TO DATE 04JUN2022 (ROLLING 12 MONTHS). ¿ INVESTIGATION RESULT / ANALYSIS: PER FSE REPORT: CLEANED OUT THE PUMP DIAPHRAGM ALONG WITH THE CONNECTORS LEADING TO THE PUMP. RAN DISPENSE PROCEDURE WITH NO WASH STATION OVERFILL ISSUES. O SAMPLE PREPARATION WAS NOT AFFECTED. THERE WAS NO DELAY IN PATIENT TREATMENT DUE TO ANY UNEXPECTED RESULTS. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER# 02479624. INSTALL DATE: 10SEP2009. DEFECTIVE PART NUMBER: THERE WERE NO DEFECTIVE PARTS. WORK ORDER NOTES: SUBJECT / REPORTED: SPA IS LEAKING. PROBLEM DESCRIPTION: FLUID LEAK. CAUSE: CLOGGED PUMP DIAPHRAGM AND FLUID LINE CONNECTORS. WORK PERFORMED: CLEANED OUT PUMP DIAPHRAGM AND FLUID LINE CONNECTORS. SOLUTION: CLEANED OUT PUMP DIAPHRAGM AND FLUID LINE CONNECTORS. RETURNED SAMPLE EVALUATION: THERE WERE NO DEFECTIVE PARTS. 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: RISK MANAGEMENT FILE PART #100245RA, REVISION 03 WAS REVIEWED. HAZARD(S) IDENTIFIED? YES OR 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: AFAP. MITIGATION(S) SUFFICIENT: YES OR NO? ROOT CAUSE: BASED ON THE INVESTIGATION RESULT AND THE FSE¿S REPORT THE ROOT CAUSE WAS A CLOGGED PUMP AND FLUID LINE CONNECTORS CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE¿S REPORT THE COMPLAINT WAS CONFIRMED FOR WASH TOWER OVERFLOWING. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO ANY INCORRECT RESULTS. THERE WAS NO IMPACT TO THE PATIENT HEALTH OR SAFETY.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD SPA BIOHAZARD LEAKED OUTSIDE OF INSTRUMENT. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: SPA IS LEAKING. THEY CLEANED THE IN-LINE FILTER BUT THAT DID NOT WORK. 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? NO. 4. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. 5. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN. 6. WAS THE WASTE MIXED WITH DECONTAMINATE/BLEACH? NO. 7. WAS THE CUSTOMER/ BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.