SYNCHRON® CX3 TOTAL PROTEIN
Received May 8, 2012 · Event occurred Apr 20, 2012
Report 2050012-2012-01120 · MDR key 2565326
Device
Generic name
Biuret (colorimetric), Total Protein
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
467501
Lot number
NA
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED APPROXIMATELY 100 MILLILITERS (ML) OF CLEAR YELLOW FLUID LEAKED FROM THE UNIT DURING PRIMING INVOLVING SYNCHRON CX3 TOTAL PROTEIN. THE CUSTOMER NOTED THE ISSUE STARTED DURING ELECTROLYTE CAM MAINTENANCE. BECKMAN COULTER CUSTOMER TECHNICAL SUPPORT (CTS) ADVISED THE CUSTOMER TO USE PROPER PERSONAL PROTECTIVE EQUIPMENT (PPE) PRIOR TO TROUBLESHOOTING: GLOVES, LABORATORY COAT, AND EYE PROTECTION DURING TROUBLESHOOTING. THE CUSTOMER DID NOT FIND ANY LOOSE OR DISCONNECTED LINE AND NOTED THE REAGENT TRAY HAD FLUID. ERRONEOUS RESULTS WERE NOT GENERATED NOR REPORTED. THE CUSTOMER HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN AT THE FACILITY. THE CUSTOMER DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO EXPOSURE TO OPEN LESIONS OR MUCUS MEMBRANES. THERE WAS NO REPORT OF INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS INCIDENT. THE FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) DISCOVERED EIC CUP OVERFLOWED CAUSED BY PINCHED TUBING. THE FSE CLEARED THE TUBING AND RESOLVED THE ISSUE. THE UNIT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS. (B)(4).