BD FACS SAMPLE PREP ASSISTANT III

Description of Event or Problem

IT WAS REPORTED THAT WHEN USING BD FACS¿ SAMPLE PREP ASSISTANT III THE WASTE LINE LEAKS OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH STATION IS OVER FLOWING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER HAS ALREADY CHANGED THE PROBE, RUN THE WEEKLY CLEAN, AND HAS CLEANED THE IN-LINE FILTER. THE FLUID WAS NOT UNDER PRESSURE AND THERE WAS NO SPRAY. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES EXPLAIN)? Y, WASH TOWER OVERFLOWED. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? N, DRIPPED ONTO THE FLOOR. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. 3. WHAT WAS THE FLUID THAT LEAKED? WASTE. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASH TOWER. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y. ADDITIONALLY, ON 2020-9-2 THE TSR PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE IS WITH THE WASH TOWER OVERFLOWING. HERE ARE A COUPLE OF PICTURES THAT MIGHT HELP. THEY SHOW THE LOCATION OF THE WASH TOWER. IT IS THE WHITE RECTANGULAR OBJECT. AS YOU CAN SEE IN THE PICTURES IT IS ACTUALLY LOCATED INSIDE OF THE INSTRUMENT. YOU CAN ALSO SEE THE WASTE LINE GOING OFF TO THE RIGHT. IT IS THE CLEAR TUBING COMING FROM THE BOTTOM OF THE WASH TOWER. THIS IS AT THE START OF THE WASTE LINE AND IS WELL BEFORE THE WASTE TANK. SINCE THE BLEACH IS IN THE WASTE TANK IT HAS NOT BEEN MIXED WITH THE BLEACH. WHEN IT THE WASH TOWER OVERFLOWS IT IS LIKE WHEN THE SINK IN YOUR KITCHEN OR BATHROOM CLOGS AND BACKS UP. SO THERE IS NO SPRAY OF FLUID AND THERE IS NO PRESSURE. IT JUST FILLS UP AND EVENTUALLY OVERFLOWS IF NOT CAUGHT IN TIME.

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY CUSTOMER REPORTED THAT ¿THE WASH STATION IS OVERFLOWING¿ THE WASTE LINE AT THE BOTTOM OF THE WASH TOWER WAS CLOGGED. THIS LINE IS BEFORE THE WASTE TANK. THE FLUID IS NOT UNDER PRESSURE AND THERE WAS NO SPRAY OF FLUIDS. THE DHR FOR SERIAL NUMBER: (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. BASED ON THE INVESTIGATION RESULT, AND THE TSR¿S REPORT THE ROOT CAUSE WAS CLOGGED INLINE FILTER. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. CAPA 681837 WAS OPENED. H3 OTHER TEXT : SEE H.10.

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 WHEN USING BD FACS¿ SAMPLE PREP ASSISTANT III THE WASTE LINE LEAKS OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH STATION IS OVER FLOWING. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: CUSTOMER HAS ALREADY CHANGED THE PROBE, RUN THE WEEKLY CLEAN, AND HAS CLEANED THE IN-LINE FILTER. THE FLUID WAS NOT UNDER PRESSURE AND THERE WAS NO SPRAY. NEXT STEPS (IF NECESSARY): DISPATCH. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES EXPLAIN)? Y, WASH TOWER OVERFLOWED. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? N, DRIPPED ONTO THE FLOOR. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK WASTE LINE OR NON-WASTE LINE? WASH TOWER WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? N. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y. ADDITIONALLY, ON 2020-9-2 THE TSR PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE IS WITH THE WASH TOWER OVERFLOWING. HERE ARE A COUPLE OF PICTURES THAT MIGHT HELP. THEY SHOW THE LOCATION OF THE WASH TOWER. IT IS THE WHITE RECTANGULAR OBJECT. AS YOU CAN SEE IN THE PICTURES IT IS ACTUALLY LOCATED INSIDE OF THE INSTRUMENT. YOU CAN ALSO SEE THE WASTE LINE GOING OFF TO THE RIGHT. IT IS THE CLEAR TUBING COMING FROM THE BOTTOM OF THE WASH TOWER. THIS IS AT THE START OF THE WASTE LINE AND IS WELL BEFORE THE WASTE TANK. SINCE THE BLEACH IS IN THE WASTE TANK IT HAS NOT BEEN MIXED WITH THE BLEACH. WHEN IT THE WASH TOWER OVERFLOWS IT IS LIKE WHEN THE SINK IN YOUR KITCHEN OR BATHROOM CLOGS AND BACKS UP. SO THERE IS NO SPRAY OF FLUID AND THERE IS NO PRESSURE. IT JUST FILLS UP AND EVENTUALLY OVERFLOWS IF NOT CAUGHT IN TIME.