COULTER LH 750 ANALYZER
Received Jun 20, 2011 · Event occurred May 20, 2011
Report 1061932-2011-00712 · MDR key 2133175
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
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND INDICATED A LEAK AT THE MANUAL MODE PROBE. TO RESOLVE THIS ISSUE THE MANUAL MODE PROBE AND THE FLUID CATCH BOX (DRIP TRAY) WERE ADJUSTED BY THE FSE. REPAIRS PER ESTABLISHED PROCEDURES WERE VERIFIED AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE FOR THE LEAK WAS ASSOCIATED TO THE MANUAL MODE PROBE. 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.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING A BLOOD FLUID LEAK (5ML) IN THE DRIP TRAY UNDER THE MANUAL SAMPLING PROBE OF THE COULTER LH 750 ANALYZER. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES AND GOGGLES AT THE TIME OF THE INCIDENT. 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 ASSOCIATED TO THIS COMPLAINT.