BD FACSCANTO¿ II FLOW CYTOMETER

Description of Event or Problem

IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING CONTINUED DURING USE WITH THE BD FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT ERROR E009 - FLOAT SWITCH TIMEOUT OCCURS WHEN PERFORMING THE LONG CLEAN. THE CUSTOMER STATED THAT SHE COULD BLEED THE BLEACH AND WATER FILTERS. SHE COULD NOT TROUBLESHOOT BECAUSE SHE HAD A LOT OF SAMPLES TO RUN. EMAIL: CUSTOMER IS REPORTING AN ERROR E009 - FLOAT SWITCH TIMEOUT WHEN PERFORMING THE LONG CLEAN. MDR SAFETY CHECKLIST -- ERROR MESSAGES. 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST?(IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED: YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED: YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED: YES. 4. IS THIS PRESTO? (EITHER YES OR NO, NO FURTHER QUESTIONS REQUIRED): NO.

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.

Description of Event or Problem

IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING CONTINUED DURING USE WITH THE BD FACSCANTO¿ II FLOW CYTOMETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT ERROR E009 - FLOAT SWITCH TIMEOUT OCCURS WHEN PERFORMING THE LONG CLEAN. THE CUSTOMER STATED THAT SHE COULD BLEED THE BLEACH AND WATER FILTERS. SHE COULD NOT TROUBLESHOOT BECAUSE SHE HAD A LOT OF SAMPLES TO RUN. EMAIL: CUSTOMER IS REPORTING AN ERROR E009 - FLOAT SWITCH TIMEOUT WHEN PERFORMING THE LONG CLEAN. MDR SAFETY CHECKLIST -- ERROR MESSAGES. 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? ((IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 4. IS THIS PRESTO? (EITHER YES OR NO, NO FURTHER QUESTIONS REQUIRED): NO.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE CONTACT - (B)(6). G.1 - MANUFACTURING SITE CONTACT - (B)(6). G.1 - REPORTING OFFICE- BECTON DICKINSON AND COMPANY BD BIOSCIENCES. H.3. BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE E009 ERROR - FLOAT SWITCH TIMEOUT WHEN PERFORMING THE LONG CLEAN WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: MANUFACTURING DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE POTENTIAL CAUSE OF THE FLOAT SWITCH TIMEOUT ERROR WAS A BAD FILTER. THE FIELD SERVICE REPRESENTATIVE (FSR) PERFORMED A SERVICE VISIT AND FOUND THAT THE FILTER ON THE FACSCLEAN OF THE WET CART WAS NOT LETTING FACSCLEAN THROUGH THE FILTER. THEY REPLACED THE FILTER AND PURGED THE AIR OUT. AFTER THE WORKS PERFORMED, THE INSTRUMENT WAS TESTED AND MEETING 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.