BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

INVESTIGATION SUMMARY: REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) AND (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE WASH TOWER WAS OVERFLOWING, DUE TO A CLOG IN THE FORWARD FILTER COUPLING, BEFORE THE FILTER AND AFTER THE WASH TOWER # (B)(4). THESE PIERCINGS ARE THE PRODUCT OF THE YELLOW TOP CAPS. THE TUBE TYPES ARE # (B)(4) YELLOW. THE PROBE HAS 978 PIERCINGS. THE LOT NUMBER OF THE PROBE IS UNKNOWN. THE FLUID WAS A COMBINATION OF WASTE, WATER AND SHEATH FLUID. THE FLUIDS WERE NOT CONTAINED IN THE SYSTEM. THE CUSTOMER WAS NOT INJURED OR HARMED AS A RESULT OF THE FLUID LEAK. THE FLUID WAS CLEANED AND DISINFECTED USING BLEACH SOLUTION. THE CLOGGED COUPLING WAS REPLACED, WHICH CORRECTED THE PROBLEM. THE INSTRUMENT IS WORKING TO SPECS. REFER TO CAPA 681837.

Description of Event or Problem

IT WAS REPORTED, THAT WHILE USING A BD FACS¿ SAMPLE PREP ASSISTANT III. BLOOD LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED, THAT THE INSTRUMENT IS LEAKING. 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. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. 3. WHAT WAS THE FLUID THAT LEAKED? BLOOD. 4. WHAT IS THE SOURCE OF LEAK, WASTE LINE OR NON-WASTE LINE? UNKNOWN. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. CUSTOMER HAD ON HER PPE. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. SOFTWARE VERSION? UNKNOWN. 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 WHILE USING A BD FACS¿ SAMPLE PREP ASSISTANT III BLOOD LEAKED OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE INSTRUMENT IS LEAKING. 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. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. WHAT WAS THE FLUID THAT LEAKED? BLOOD. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? UNKNOWN. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO - CUSTOMER HAD ON HER PPE. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK NO. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? UNKNOWN. FOLLOW UP REQUIRED (Y/N)? UNKNOWN. LIST OF PARTS SHIPPED (INCLUDE FOC): UNKNOWN. RMA REQUIRED (Y/N)? UNKNOWN.