COULTER LH 750 ANALYZER
Received Jun 20, 2011 · Event occurred May 20, 2011
Report 1061932-2011-00711 · MDR key 2133174
Device
Generic name
Automated Differential Cell Counter
Manufacturer
Beckman Coulter, Inc.Model number
LH 750Catalog number
6605632
Lot number
N/A
Product problems
- Fluid/Blood Leak
- Split
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A BLOOD SPILL (5 ML) COMING FROM THE FLOW CELL AREA WHERE A SPLIT TUBING WAS OBSERVED GOING FROM THE MIX CHAMBER TO THE BOTTOM OF THE FLOW CELL OF THE COULTER LH 750 ANALYZER. THE USER WAS WEARING FULL PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND CONFIRMED THE LEAK. PER THE FSE, THE LEAK WAS COMING OUT OF THE DIFFERENTIAL SAMPLE LINE CONNECTING THE MIXING CHAMBER AND THE FLOW CELL AT THE PINCH POINT. THE FSE REPLACED THE TUBE. THE REPAIRS PER ESTABLISHED PROCEDURES WERE VERIFIED AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE FOR THE LEAK WAS ASSOCIATED WITH SPLIT TUBING IN THE DIFFERENTIAL SAMPLE LINE. 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.