COULTER LH 750 SLIDEMAKER ANALYZER
Received Jun 20, 2011 · Event occurred May 20, 2011
Report 1061932-2011-00710 · MDR key 2133177
Device
Generic name
Automated Differential Cell Counter
Manufacturer
Beckman Coulter, Inc.Model number
LH 750Catalog number
6605645
Lot number
N/A
Product problems
- Leak/Splash
- Split
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE CUSTOMER FOUND FLUID IN THE TUBING TRAY ON THE COULTER LH 750 SLIDEMAKER ANALYZER. PER THE CUSTOMER, THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND APPEARED TO BE METHANOL REAGENT FROM THE SPLIT TUBING ON THE PUMP 1 FOR BATH 1. THE CUSTOMER DOES NOT HAVE A SPARE PUMP AND REQUESTED INSTRUMENT SERVICE. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS COMPLAINT.
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND FOUND THE LEAK AT THE TUBING ON THE PERISTALTIC PUMP 1 AND REPLACED THE BATH 1 PERISTALTIC PUMP AND TUBING. THE FSE VERIFIED THE INSTRUMENTS OPERATION. THE ROOT CAUSE WAS ATTRIBUTED TO A LEAK FROM THE TUBING ASSOCIATED WITH THE BATH 1 PERISTALTIC PUMP. PER LABELING, BECKMAN COULTER, INC. URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.