BD FACSLYRIC¿
Received Apr 23, 2025 · Event occurred Apr 3, 2025
Report 3027394506-2025-00019 · MDR key 21892324
Device
Generic name
Flow Cytometric Reagents And Access
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
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 WHILE USING BD FACSLYRIC¿ IT FAILED TO PULL AWAY ASPIRATION COMPLETELY DURING SIT FLUSH CAUSING CARRY OVER BETWEEN SAMPLES. NO PATIENT INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE IS NOT BEING PULLED AWAY COMPLETELY. MACHINE FAILED TO PULL AWAY ASPIRATION DURING SIT FLUSH CAUSING CARRY OVER BETWEEN SAMPLES.
Additional Manufacturer Narrative
H.6: INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED CONTAMINATION CARRY OVER ISSUE WAS CONFIRMED. THE CAUSE OF THE COMPLAINT WAS A CLOGGED WASTE LINE. THE CUSTOMER ATTEMPTED TO RESOLVE THE ISSUE ON THEIR OWN BY REPLACING THE SAMPLE LINE, BUT THIS DID NOT RESOLVE THE ISSUE. A FIELD SERVICE ENGINEER (FSE) WAS SENT ONSITE FOR A FIELD SERVICE VISIT, AND THEY WERE ABLE TO CONFIRM THAT THERE WAS A CLOG IN THE SIT FLUSH DRAIN LINE. THE FSE THEN CLEARED THE DEBRIS WITH WARM BLEACHED WATER AND SEVERAL SIT FLUSHES. FINALLY, THE FSE COMPLETED PQC AND ABORT COUNT CHECKS AND CONFIRMED THAT THE INSTRUMENT WAS PERFORMING TO BD SPECIFICATIONS. THERE WAS NO IMPACT TO CUSTOMER OR PATIENT SAFETY DUE TO THIS EVENT. A RETURN SAMPLE WAS NOT REQUESTED FOR EVALUATION AS THE ROOT CAUSE OF THE ISSUE WAS IDENTIFIED WITHOUT REQUIRING A SAMPLE ANALYSIS. 4 COMPLAINTS REGARDING SIMILAR ISSUES REGARDING CLOGGED TUBING AND RESULTING CARRYOVER WERE IDENTIFIED WITHIN 12 MONTHS OF THIS EVENT. DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT REQUIRED AS THE ROOT CAUSE WAS IDENTIFIED IN THE FIELD.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ IT FAILED TO PULL AWAY ASPIRATION COMPLETELY DURING SIT FLUSH CAUSING CARRY OVER BETWEEN SAMPLES. NO PATIENT INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASTE IS NOT BEING PULLED AWAY COMPLETELY MACHINE FAILED TO PULL AWAY ASPIRATION DURING SIT FLUSH CAUSING CARRY OVER BETWEEN SAMPLES.