COULTER® LH 750 SLIDEMAKER
Received May 20, 2011 · Event occurred Apr 22, 2011
Report 1061932-2011-00435 · MDR key 2098073
Device
Generic name
Slidemaker
Manufacturer
Beckman Coulter Inc.Model number
NACatalog number
6605645
Lot number
NA
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
BCI HOTLINE PERFORMED TROUBLESHOOTING OVER THE PHONE AND OPERATOR FOUND A LOOSE LINE. THE CUSTOMER RECONNECTED THE LINE AND CLEANED THE TUBING TRAY. HOWEVER, WHEN THE BATH DRAIN WAS RECYCLED, THE LINE POPPED OFF AGAIN DRIPPING DI WATER ON TO TRAY. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON-SITE. FSE INDICATED THE WASTE PUMP WAS UNPLUGGED AND THE REPLACED THE PLUGGED WASTE FITTING. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER STATING THAT THE COULTER LH 750 SLIDESTAINER UNIT WAS RUNNING WHEN IT ALERTED THE USER FOR FLUID IN THE TUBING TRAY. THERE WAS SOME CLEAR LIQUID (DI WATER) OBSERVED IN THE BOTTOM OF THE TUBING TRAY. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) AT THE TIME OF THE EVENT AND WAS NOT EXPOSED TO ANY BIOHAZARD (ONLY DI WATER). THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO INJURY WAS REPORTED AND MEDICAL ATTENTION WAS NOT SOUGHT.