BD FACSLYRIC

Additional Manufacturer Narrative

H.6. INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND, DEVICE HISTORY RECORD (DHR), AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CARRYOVER WAS DUE TO KINKED TUBING. TUBING WAS REPLACED, THE WASTE TUBING WAS REARRANGED AND LONG CLEAN WAS PERFORMED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

Description of Event or Problem

IT WAS REPORTED THAT SAMPLE CARRYOVER WAS OBSERVED DURING USE WITH THE BD FACSLYRIC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST : 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.: CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST: BACKFLUSH/SAMPLE CARRYOVER IN THE WATER TUBE WITH RESIDUAL BLOOD. BACKFLUSH/SAMPLE CARRYOVER IN THE WATER TUBE WITH RESIDUAL BLOOD AFTER SHUTDOWN YESTERDAY. IT HAPPENS WHEN THE MACHINE IS SITTING IDLE AND BLOOD CAN BE SEEN IN TUBE ON THE SIT.

Description of Event or Problem

IT WAS REPORTED THAT SAMPLE CARRYOVER WAS OBSERVED DURING USE WITH THE BD FACSLYRIC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MDR SAFETY CHECKLIST : 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.: CARRYOVER BETWEEN PATIENT SAMPLES. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST: BACKFLUSH/SAMPLE CARRYOVER IN THE WATER TUBE WITH RESIDUAL BLOOD. BACKFLUSH/SAMPLE CARRYOVER IN THE WATER TUBE WITH RESIDUAL BLOOD AFTER SHUTDOWN YESTERDAY. IT HAPPENS WHEN THE MACHINE IS SITTING IDLE AND BLOOD CAN BE SEEN IN TUBE ON THE SIT.

Additional Manufacturer Narrative

D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.