BD FACSLYRIC¿

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CONTAMINATION AND CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CONTAMINATION AND CARRYOVER WAS DETERMINED TO BE LINKED TO A DEFECTIVE PUMP IN THE FLUIDIC SYSTEM. THE ISSUE WAS RESOLVED AFTER THE PART WAS REPLACED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED.

Description of Event or Problem

IT WAS REPORTED THAT CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED AFTER USAGE OF BD FACSLYRIC¿ . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOKE WITH CUSTOMER AND THEY ARE GETTING LASER DELAY SETUP ERRORS DURING PQC. THEY HAVE COMPLETED A FEW LONG CLEANS IN THE LAST FEW WEEKS BECAUSE THEY ARE STILL HAVING SOME CARRYOVER ISSUES BETWEEN SAMPLES. SYSTEM HAS BEEN HAVING ISSUES WITH CARRYOVER, CLEANING THE SYSTEM CLEARS UP THE ISSUE BUT IT COMES BACK AFTER A FEW DAYS. NO RESULTS WERE USED IF CARRYOVER WAS PRESENT.

Additional Manufacturer Narrative

ADDITIONAL PMA/510K CODES ARE: K170974, K201814. 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 CARRYOVER BETWEEN PATIENT SAMPLES WAS OBSERVED AFTER USAGE OF BD FACSLYRIC¿ . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOKE WITH CUSTOMER AND THEY ARE GETTING LASER DELAY SETUP ERRORS DURING PQC. THEY HAVE COMPLETED A FEW LONG CLEANS IN THE LAST FEW WEEKS BECAUSE THEY ARE STILL HAVING SOME CARRYOVER ISSUES BETWEEN SAMPLES. SYSTEM HAS BEEN HAVING ISSUES WITH CARRYOVER, CLEANING THE SYSTEM CLEARS UP THE ISSUE BUT IT COMES BACK AFTER A FEW DAYS. NO RESULTS WERE USED IF CARRYOVER WAS PRESENT.