BD FACS¿ SAMPLE PREP ASSISTANT III
Received Sep 25, 2025 · Event occurred Sep 15, 2025
Report 3027394506-2025-00041 · MDR key 23144122
Device
Generic name
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cyto
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
650686
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G04054. H.6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF SAMPLE CARRYOVER AND DEBRIS WAS CONFIRMED. THE POTENTIAL CAUSE WAS DETERMINED TO BE A CLOGGED WASTE IN-LINE FILTER. THE FIELD SERVICE ENGINEER INVESTIGATED THE ISSUE AND REPLACED THE FILTER AND ITS QUICK-CONNECT COUPLINGS, WHICH RESOLVED THE ISSUE AND RETURNED THE INSTRUMENT TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT, AND NO USER OR PATIENT WAS HARMED OR INJURED. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION. DEVICE HISTORY RECORD REVIEW WAS NOT REQUIRED AS THE COMPLAINT WAS CONFIRMED THROUGH OTHER ELEMENTS OF THE INVESTIGATION.
Description of Event or Problem
IT WAS REPORTED THAT CARRYOVER WAS OBSERVED BETWEEN PATIENT SAMPLES DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. ANS: CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. ANS: THEY ARE SEEING CELLULAR CARRYOVER IN THEIR PBS TUBE.
Description of Event or Problem
IT WAS REPORTED THAT CARRYOVER WAS OBSERVED BETWEEN PATIENT SAMPLES DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION: 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2. ANS: CARRYOVER BETWEEN PATIENT SAMPLES 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. ANS: THEY ARE SEEING CELLULAR CARRYOVER IN THEIR PBS TUBE.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.