BD FACS SAMPLE PREP ASSISTANT

Additional Manufacturer Narrative

AFTER FURTHER REVIEW MFR#2916837-2020-00259 IS NO LONGER REPORTABLE. THIS DEVICE IS FOR RESEARCH USE ONLY AND IS NOT BEING USED FOR DIAGNOSTIC TESTING OR PATIENT TREATMENT AND IS THEREFORE NOT SUBJECT TO MDR REPORTING.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT WASTE LEAKED OUTSIDE OF INSTRUMENT. THE RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THE WASH STATION IS OVERFLOWING. CLEANING THE INLINE FILTER DOES NOT RESOLVE THE ISSUE, THE INSTRUMENT HAS BEEN PLACED DOWN AND OUT OF SERVICE. THERE WAS NO SPRAY OF LIQUID UNDER PRESSURE. WAS THE WASTE MIXED WITH DECONTAMINATE OR BLEACH? NO. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: WASH STATION IS OVERFLOWING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THE CUSTOMER REPORTS THAT THE WASH STATION IS OVERFLOWING. CLEANING THE INLINE FILTER DOES NOT RESOLVE THE ISSUE, THE INSTRUMENT HAS BEEN PLACED DOWN AND OUT OF SERVICE. NEXT STEPS (IF NECESSARY): DISPATCHING THE CALL. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? NO. SOFTWARE VERSION? NA. LIST OF PARTS SHIPPED (INCLUDE FOC): NA. RMA REQUIRED? NA. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE. WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO.

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ SAMPLE PREP ASSISTANT WASTE LEAKED OUTSIDE OF INSTRUMENT. THE RESULTS WERE NOT REPORTED AND THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THE WASH STATION IS OVERFLOWING. CLEANING THE INLINE FILTER DOES NOT RESOLVE THE ISSUE, THE INSTRUMENT HAS BEEN PLACED DOWN AND OUT OF SERVICE. THERE WAS NO SPRAY OF LIQUID UNDER PRESSURE. WAS THE WASTE MIXED WITH DECONTAMINATE OR BLEACH? NO. IS INSTRUMENT ASSURITY LINC ENABLED? NO. CUSTOMER PROBLEM: WASH STATION IS OVERFLOWING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: THE CUSTOMER REPORTS THAT THE WASH STATION IS OVERFLOWING. CLEANING THE INLINE FILTER DOES NOT RESOLVE THE ISSUE, THE INSTRUMENT HAS BEEN PLACED DOWN AND OUT OF SERVICE. NEXT STEPS (IF NECESSARY): DISPATCHING THE CALL. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? YES. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? NO. WAS THERE ANY INJURY OR POTENTIAL INJURY? NO. RESOLUTION ACHIEVED? NO. FOLLOW UP REQUIRED? NO. SOFTWARE VERSION? NA. LIST OF PARTS SHIPPED (INCLUDE FOC): NA. RMA REQUIRED? NA. WAS THERE A FLUIDIC LEAK OR SPILL? YES. WAS THE LEAK/SPILL CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK/SPILL IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED/SPILLED? WASTE WHAT IS THE SOURCE OF LEAK/SPILL? (WASTE OR NON-WASTE LINE) WASTE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO.