BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

H6: INVESTIGATION SUMMARY: THE FSE CLEARED AND FLUSHED IN-LINE WASTE FILTER AND WASH PUMP. THIS ALLOWED THE WASH STATION TO DRAIN BUT NOT COMPLETELY. FSE THEN FOUND ADDITIONAL CLOGGING IN THE QUICK-CONNECT FITTING OF THE WASTE LINE AT THE FLUID TOWER. AFTER REPLACING THAT FITTING FLUID WAS ABLE TO FLOW FREELY TO THE WASTE TANK. SINCE THE WASTE LEAK WAS NOT SPECIFICALLY AT THE WASTE TANK, THE WASTE WAS NOT MIXED WITH BLEACH. 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 WAS RETURNED TO THE LAB FOR NORMAL USE. ROOT CAUSE: BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS CLOGGED WASTE LINES. CONCLUSION: BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT III THE WASTE LINE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH STATION IS CLOGGED. 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. LEAK (IF YES EXPLAIN)? YES. WASH STATION OVERFLOWED. NO PRESSURE OR SPRAY. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 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 LINE. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. SOFTWARE VERSION? 5. RESOLUTION ACHIEVED (Y/N)? UNKNOWN. FOLLOW UP REQUIRED (Y/N)? UNKNOWN. LIST OF PARTS SHIPPED (INCLUDE FOC): UNKNOWN. RMA REQUIRED (Y/N)? UNKNOWN.

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 THE WASTE LINE LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE WASH STATION IS CLOGGED. 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 LEAK (IF YES EXPLAIN)? YES. WASH STATION OVERFLOWED. NO PRESSURE OR SPRAY. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 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 LINE 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 SOFTWARE VERSION? RESOLUTION ACHIEVED (Y/N) UNKNOWN. FOLLOW UP REQUIRED (Y/N)? UNKNOWN. LIST OF PARTS SHIPPED (INCLUDE FOC): UNKNOWN. RMA REQUIRED (Y/N)? UNKNOWN.