BD FACSLYRIC¿

Additional Manufacturer Narrative

E.1. INITIAL REPORTER ADDRESS 1: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS CONTAMINATION/ ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION AND PATIENT SAMPLE CHECKLIST SNIP ATTACHED. 1. WERE SAMPLES CONTAMINATED? (IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES OR UNKNOWN, GO TO PATIENT SAMPLES CHECKLIST): YES. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO. THE CUSTOMER REPORTED THERE OCCURS CONTAMINATION, THE NEEDLE STAYS RED ALL THE TIME. CUSTOMER DID CLEANING WITH CONTRAD AND ETHANOL AND THE DAILY CLEANING, BUT PROBLEM PERSISTS.

Additional Manufacturer Narrative

H.6. BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE CONTAMINATION WAS NOT CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE POTENTIAL CAUSE FOR THE CONTAMINATION COULD NOT BE DETERMINED. IN AN ATTEMPT TO RESOLVE THE ISSUE, THE FIELD SERVICE ENGINEER (FSE) PERFORMED A REPAIR ON THE FLUIDIC SUBSYSTEM. THEY PERFORMED A SERIES OF WORKS INCLUDING ¿ VERIFYING THE SIT FLUSH SETTINGS, CLEANING THE FLOW CELL WITH FACSCLEAN AND CONTRAD AND PREVENTIVE MAINTENANCE OF THE SAMPLE LINE. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS TESTED AND WAS CONFIRMED TO BE PERFORMING ACCORDING TO SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS CONTAMINATION/ ERRONEOUS RESULTS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACSLYRIC¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTAMINATION AND PATIENT SAMPLE CHECKLIST SNIP ATTACHED. 1. WERE SAMPLES CONTAMINATED? (IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES OR UNKNOWN, GO TO PATIENT SAMPLES CHECKLIST): YES 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED): NO THE CUSTOMER REPORTED THERE OCCURS CONTAMINATION, THE NEEDLE STAYS RED ALL THE TIME. CUSTOMER DID CLEANING WITH CONTRAD AND ETHANOL AND THE DAILY CLEANING, BUT PROBLEM PERSISTS.