BD FACSLYRIC¿ FLOW CYTOMETER
Received Jul 3, 2025 · Event occurred Jun 17, 2025
Report 3027394506-2025-00031 · MDR key 22399344
Device
Generic name
Flow Cytometric Reagents And Accessories
Manufacturer
Becton, Dickinson And Company, Bd BiosciencesCatalog number
663518
Product problems
- Contamination
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
E.1. INITIAL REPORTER PHONE #: (B)(6). E.1. INITIAL REPORTER FACILITY NAME: (B)(6). G.5. PMA / 510(K) ADDITIONAL #170974; K201814. H.3. 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 DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER INVOLVING PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: LARGE SAMPLE RESIDUE.
Additional Manufacturer Narrative
H.6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE LARGE SAMPLE RESIDUE WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: DEVICE HISTORY REVIEW (DHR), COMPLAINT HISTORY REVIEW, AND SERVICE HISTORY REVIEW. THE POTENTIAL CAUSE FOR THE LARGE SAMPLE RESIDUE WAS FAULTY PUMP AND DEGASSER. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE FAULTY PARTS. AFTER THE REPLACEMENT, THE INSTRUMENT WAS TESTED AND WAS CONFIRMED TO BE PERFORMING ACCORDING TO SPECIFICATIONS.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSLYRIC¿ FLOW CYTOMETER CARRYOVER INVOLVING PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: LARGE SAMPLE RESIDUE.