COULTER LH 750 SLIDEMAKER ANALYZER

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED A LEAK IN THE RED STRIPE SAMPLE DISPENSE TUBING. THE TUBING WAS REPLACED AND THE SPILL WAS CLEANED. REPAIRS PER ESTABLISHED PROCEDURES WERE VERIFIED AND RESULTS MEET PUBLISHED PERFORMANCE SPECIFICATIONS. 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) STATING THAT A TUBING LEAK OF <1 ML OF BLOOD AND DILUENT OCCURRED IN THE COULTER LH 750 SLIDEMAKER ANALYZER. THE USER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LAB COAT, GLOVES AND EYE PROTECTION AT THE TIME OF THE INCIDENT. NO ONE WAS CONTAMINATED; NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THE SPILL WAS CLEANED UP ACCORDING TO THE DEFINED LABORATORY PROTOCOL. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR ASSOCIATED TO THIS COMPLAINT.