BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OCCURRING ON PATIENTS SAMPLES WITH A BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD SOME PROBLEMS WITH OUR SAMPLE PREP ASSISTANT (SERIAL NUMBER (B)(6) IT HAD AN ENGINEER VISIT AND THEN A SECOND VISIT TO PERFORM THE PM. HOWEVER WE ARE STILL NOT SATISFIED WITH THE PERFORMANCE. FOR EXAMPLE THERE ARE REGULAR OCCURRENCES OF MIS-SAMPLING EVEN WHEN THE TUBE IS SUFFICIENTLY FILLED. THIS HAPPENED ON 3 OUT OF 20 SAMPLES PROCESSED LAST WEEK. THE WORRY IS WE MIGHT NOT NOTICE AND REPORT INCORRECTLY LOW NUMBERS AS THESE ARE ONLY SPOTTED WHEN SAMPLES APPEAR PALE IN COLOR OR WE HAVE A LYMPHOCYTE COUNT FROM A SECOND SOURCE (HEMATOLOGY ANALYZER) THAT IS DISCREPANT. ADDITIONALLY ON THURSDAY AFTER A RUN OF 3 SAMPLES THERE WERE DROPS OF BLOOD IN THE ANALYZER. ADDITIONALLY, ON 2020-05-04 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WERE PATIENT SAMPLES AFFECTED? YES. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? OBTAINED IN SOME INSTANCES BUT NOT USED (TESTING WAS REPEATED). ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? NO. WAS THERE ANY HARM TO THE PATIENT? NO.

Additional Manufacturer Narrative

H.6. INVESTIGATION: SCOPE OF ISSUE: THE SCOPE OF ISSUE IS LIMITED TO SPAIII SN: (B)(6). PROBLEM STATEMENT: CUSTOMER REPORTED MIS-SAMPLING ISSUE. (B)(6) 2020. MANUFACTURING DEFECT TREND: THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS). RELATED QN(S) NUMBER 0. COMPLAINT TREND: THERE ARE 5 COMPLAINTS RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM (B)(6) 2019 TO DATE (B)(6) 2020 (ROLLING 12 MONTHS) MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: A REVIEW OF DHR PN647205 SERIAL NUMBER (B)(6) MFG DATE: 05AUG2010. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE INVESTIGATION RESULT / ANALYSIS: PER SERVICE MAX INTERNAL NOTES: BASED ON PHOTOS AND DISCUSSION WITH THE CUSTOMER THE ISSUE EITHER COMES FROM AIR IN THE SYSTEM, OR RECAPPED VACUTAINER TUBES THAT HAVE NOT BEEN VENTED AFTER THE CAP HAS BEEN REPLACED. AN "INACCURATE OR MISSED SAMPLE" MAY OCCUR DUE TO THE FLUIDICS DISPLACEMENT WHEN PIERCING THE UNVENTED SAMPLE TUBE. THIS CONDITION WILL NOT ALLOWING A FULL ASPIRATION OF THE SAMPLE. THE BD FACS SAMPLER PREP ASSISTANT III INSTRUCTIONS FOR USE DOCUMENT NUMBER 23-13406-02 IN SECTION: SAMPLE PREPARATION - "VENTING PRIMARY SAMPLE TUBES" PAGE 106 PROVIDES INSTRUCTIONS FOR VENTING RECAPPED SAMPLE TUBES. THE VENT TUBE TOOL HAS BEEN PROVIDED TO THE CUSTOMER. FSE IS WAITING FOR RESPONSE FROM THE CUSTOMER. THE INVESTIGATION IS INCOMPLETE. THE WO01447821 IS NOT RESOLVED. SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER (B)(4) . INSTALL DATE:(B)(6) 2010.. DEFECTIVE PART NUMBER: NO DEFECTIVE PARTS . WORK ORDER NOTES: O SUBJECT / REPORTED: MISSED/INCOMPLETE SAMPLES. O PROBLEM DESCRIPTION: INCOMPLETE SAMPLE. O CAUSE: CANNOT BE DETERMINED. O WORK PERFORMED: PM. O SOLUTION: RETURNED SAMPLE EVALUATION: NO REQUEST WAS MADE BECAUSE NO DEFECTIVE PART WAS REPLACED. CUSTOMER WAS PROVIDED WITH VENTING TOOL 346880 TO RESOLVE THE ISSUE RISK ANALYSIS: THE CONDITIONS IDENTIFIED WERE REVIEWED IN RISK ANALYSIS 100245RA REV 02. HAZARD(S) IDENTIFIED?YES NO. IF NO (TO ABOVE), WHAT ACTIONS WILL BE TAKEN. HAZARD ID: 3.1.9. HAZARD: INSUFFICIENT SAMPLE VOLUME. CAUSE: PROBE DOES NOT ASPIRATE ENOUGH VOLUME FOR TEST. HARMFUL EFFECTS: INCORRECT OR NO RESULTS. PROBABILITY: 2. SEVERITY: 2. RISK INDEX: 4. INITIAL RISK EVALUATION: ACCEPTABLE. RISK CONTROL: USER GUIDE RECOMMENDS MINIMUM VOLUMES. IMPLEMENTATION: USER¿S GUIDE. NEW HAZARDS: NO NEW HAZARDS. MITIGATION(S) SUFFICIENT YES NO. ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS, ROOT CAUSE CANNOT BE DETERMINED. FSE PROVIDED CUSTOMER WITH VENTING TOOL 346880 TO RESOLVE THE ISSUE. CONCLUSION: BASED ON THE INVESTIGATION RESULTS, COMPLAINT WAS UNCONFIRMED H3 OTHER TEXT : SEE H.10.

Additional Manufacturer Narrative

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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 ERRONEOUS RESULTS WERE OCCURRING ON PATIENTS SAMPLES WITH A BD FACS SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD SOME PROBLEMS WITH OUR SAMPLE PREP ASSISTANT (SERIAL NUMBER (B)(4)), IT HAD AN ENGINEER VISIT AND THEN A SECOND VISIT TO PERFORM THE PM. HOWEVER WE ARE STILL NOT SATISFIED WITH THE PERFORMANCE. FOR EXAMPLE THERE ARE REGULAR OCCURRENCES OF MIS-SAMPLING EVEN WHEN THE TUBE IS SUFFICIENTLY FILLED. THIS HAPPENED ON 3 OUT OF 20 SAMPLES PROCESSED LAST WEEK. THE WORRY IS WE MIGHT NOT NOTICE AND REPORT INCORRECTLY LOW NUMBERS AS THESE ARE ONLY SPOTTED WHEN SAMPLES APPEAR PALE IN COLOR OR WE HAVE A LYMPHOCYTE COUNT FROM A SECOND SOURCE (HEMATOLOGY ANALYZER) THAT IS DISCREPANT. ADDITIONALLY ON THURSDAY AFTER A RUN OF 3 SAMPLES THERE WERE DROPS OF BLOOD IN THE ANALYZER. ADDITIONALLY, ON (B)(6) 2020 THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: WERE PATIENT SAMPLES AFFECTED? YES. IF THEY WERE PATIENT SAMPLES, WERE INCORRECT RESULTS OBTAINED OR USED? OBTAINED IN SOME INSTANCES BUT NOT USED (TESTING WAS REPEATED). ANY TREATMENT PROVIDE TO THE PATIENT BASED ON THE RESULT? NO. WAS THERE ANY HARM TO THE PATIENT? NO