UNICEL® DXH SLIDEMAKER STAINER COULTER® CELLULAR ANALYSIS SYSTEM
Received Mar 18, 2013 · Event occurred Feb 17, 2013
Report 1061932-2013-00342 · MDR key 3008064
Device
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM LEAKED APPROXIMATELY 3 ML OF CLEAR FLUID DURING SHUTDOWN. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING GLOVES AND A LAB COAT AT THE TIME OF THE EVENT. THERE WAS NO INJURY OR EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES, AND THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. MSDS WAS NOT REVIEWED, BUT THE FACILITY HAS AN EXPOSURE CONTROL PLAN. NO ERRONEOUS RESULTS WERE GENERATED.
Additional Manufacturer Narrative
BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THAT THE SOURCE OF THE LEAK WAS THE WASH COLLAR WHICH NEEDED ALIGNMENT. THE FSE PERFORMED THE WASH COLLAR ALIGNMENT FOLLOWED BY DAILY CHECKS AS WELL AS SHUTDOWNS. NO FURTHER EVIDENCE OF LEAKING WAS OBSERVED. (B)(4).