BD FACSCANTO¿ II FLOW CYTOMETER

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. D.4. MEDICAL DEVICE EXPIRATION DATE: NA H3 OTHER TEXT : SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD FAILED TO START UP. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS ERROR HAPPENED ON STARTUP. CUSTOMER HAD COMPLETED A LONG CLEAN ON THE INSTRUMENT, BUT IT STILL FAILS, WET CART PRESSURE APPEARS TO BE LOW. REQUESTING FSE ONSITE TO REPAIR. CUSTOMER STATED THAT SHE CAN HEAR AN ODD NOISE WHEN STARTING THE SYSTEM AND SHE IS GETTING AN E011 ERROR." "MDR SAFETY CHECKLIST - ERROR MESSAGES (CASE): 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2.:NO. 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.:YES. 3. WERE PATIENT SAMPLES RUN ON THE INSTRUMENT AFTER AN ERROR MESSAGE WAS DISPLAYED? IF YES, GO TO PATIENT SAMPLES CHECKLIST. IF NO, NO FURTHER QUESTIONS REQUIRED.:YES"

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF OBTAINING AN E011 ERROR CODE AND FAILING AT STARTUP 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 OBTAINING AN E011 ERROR CODE AND FAILING AT STARTUP WAS DUE TO A WORN FLUIDIC MANIFOLD IN THE WETCART. THE ISSUE WAS RESOLVED AFTER THE PART WAS REPLACED. 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. 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 WHILE USING BD FACSCANTO II CYTOMETER 4/2 SYSTEM IVD FAILED TO START UP. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS ERROR HAPPENED ON STARTUP. CUSTOMER HAD COMPLETED A LONG CLEAN ON THE INSTRUMENT, BUT IT STILL FAILS, WET CART PRESSURE APPEARS TO BE LOW. REQUESTING FSE ONSITE TO REPAIR. CUSTOMER STATED THAT SHE CAN HEAR AN ODD NOISE WHEN STARTING THE SYSTEM AND SHE IS GETTING AN E011 ERROR." "MDR SAFETY CHECKLIST - ERROR MESSAGES (CASE) 1. IS THIS FACSPRESTO OR FACSCOUNT? IF YES, NO FURTHER QUESTIONS REQUIRED. IF NO, GO TO QUESTION #2.:NO. 2. DID THE INSTRUMENT DISPLAY AN ERROR MESSAGE? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.:YES. 3. WERE PATIENT SAMPLES RUN ON THE INSTRUMENT AFTER AN ERROR MESSAGE WAS DISPLAYED? IF YES, GO TO PATIENT SAMPLES CHECKLIST. IF NO, NO FURTHER QUESTIONS REQUIRED.:YES."