BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: PER FSE REPORT: REPLACED THE CLOGGED FITTING. FLUSHED THE IN-LINE FILTER, FITTINGS AND LINES AND PRIMED THE SYSTEM MULTIPLE TIMES TO VERIFY PROPER ASPIRATION OF WASTE FROM THE WASH TOWER. FLUIDS WERE CONTAINED WITHIN THE SYSTEM. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. REPLACING THE CLOGGED FITTING AND FLUSHING THE WASTE LINE RESOLVED THE ISSUE. THE INSTRUMENT IS OPERATING AS INTENDED AND TESTING WITHOUT ERRORS. IT HAS BEEN RETURNED TO THE LAB FOR NORMAL USE. BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED WASTE LINES. H3 OTHER TEXT : SEE H10.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO, SOME WOULD HAVE SPILLED ONTO COUNTER. 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? WASTE/WASH TOWER FOR PROBE. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NOT DIRECTLY - FULL PPE ON TO CLEAN UP THE FLUID. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: HERE WAS NO PRESSURE OR SPRAY, JUST AN OVERFLOW. THE WASTE WOULD NOT HAVE BEEN MIXED WITH ANY BLEACH OR DECONTAMINATE AT THAT LOCATION.

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 A BD FACS¿ SAMPLE PREP ASSISTANT III WASTE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH STATION IS OVERFLOWING. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO, SOME WOULD HAVE SPILLED ONTO COUNTER. 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? WASTE/WASH TOWER FOR PROBE WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NOT DIRECTLY - FULL PPE ON TO CLEAN UP THE FLUID. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. ADDITIONALLY, THE FSE PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: HERE WAS NO PRESSURE OR SPRAY, JUST AN OVERFLOW. THE WASTE WOULD NOT HAVE BEEN MIXED WITH ANY BLEACH OR DECONTAMINATE AT THAT LOCATION.