COULTER LH 750 ANALYZER

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THERE WAS A MIXTURE OF BLOOD AND CLENZ IN THE DRIP TRAY UNDERNEATH THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER LH 750 ANALYZER. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THERE WAS NO EXPOSURE, OR CONTACT WITH EYES OR SKIN, OPEN WOUNDS OR MUCOUS MEMBRANE. THERE WAS NO EFFECT TO PATIENTS OR END USERS.

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 FOR THIS EVENT. THE FSE FOUND THE TUBING ON THE TOP OF THE VACUUM CHAMBER CRIMPLED UNDER THE BLOOD DETECTOR BRACKET. THE FSE CORRECTED THE TUBING ROUTING. THE FSE ALSO FOUND THE INCORRECT FITTING ON THE QUICK DISCONNECT FOR THE RINSE CUP DRAIN. PER THE FSE, THE FITTING WAS TOO SMALL ALLOWING A BREAK IN VACUUM, THUS THE FSE REPLACED IT WITH THE CORRECT FITTING. THE FSE ALSO REPLACED THE LEAKING PNEUMATIC TUBING ON THE BLOOD SAMPLING VALVE (BSV) LEFT PAD ACTUATOR. THE ROOT CAUSE OF THE LEAK IS THE BLOOD SAMPLING VALVE (BSV) NOT BEING IN THE CORRECT POSITION TO DELIVER THE BLOOD DUE TO THE LEAK ON THE PNEUMATIC TUBING ON THE LEFT CYLINDER. AS PER PRODUCT 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.