BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART
Received Oct 27, 2023 · Event occurred Oct 4, 2023
Report 2916837-2023-00208 · MDR key 18017514
Device
Generic name
Counter, Differential Cell
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
338962
Lot number
NA
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: G.1 - REPORTING OFFICE - (B)(6). H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF EXPERIENCING FAILURE TO PRESSURIZE THE 1ST FEW SAMPLES AND UNABLE TO RUN EXTENDED CLEANING 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 FAILURE TO PRESSURIZE THE 1ST FEW SAMPLES AND UNABLE TO RUN EXTENDED CLEANING WAS DUE TO A WORN R2 SHEATH/SAMPLE REGULATOR. 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 DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART ERROR MESSAGE OCCURRED, CUSTOMER BYPASSED AND CONTINUE TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN RUN CAROUSEL IT FAILS TO PRESSURIZE 1ST FEW SAMPLES, ERROR MESSAGE (#COULD NOT PRESSURIZE).
Description of Event or Problem
IT WAS REPORTED THAT DURING USE WITH BD FACSCANTO¿ II SYSTEM W/FLUIDICS CART ERROR MESSAGE OCCURRED, CUSTOMER BYPASSED AND CONTINUE TESTING. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WHEN RUN CAROUSEL IT FAILS TO PRESSURIZE 1ST FEW SAMPLES, ERROR MESSAGE (#COULD NOT PRESSURIZE). 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
H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.