COULTER® LH 750 SLIDEMAKER

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK OF 3ML OF BLOODY FLUID THAT WAS DISCOVERED IN A COULTER LH 750 SLIDEMAKER WHILE TROUBLESHOOTING A PRINTER ERROR ON THE RIGHT SIDE NEAR THE DISPENSE PROBE. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES AND FACE SHIELD AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO IMPACT TO PATIENT SAMPLES OR RESULTS.

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND INDICATED THAT EXCESSIVE BLOOD SPLATTER WAS IDENTIFIED ON THE INSTRUMENT WHICH CONFIRMED THE LEAK. FSE REPORTED THAT THE BLOOD SAMPLE WASTE WAS UNABLE TO DRAIN CORRECTLY DUE TO INADEQUATE VACUUM DURING DRAINING. FSE CLEANED THE RINSE BLOCK AND CHECKED PORTS FOR PARTIAL PLUGS. FSE ALSO BACKWASHED THE VACUUM LINES WITH DISTILLED WATER AND DRAINED THE VACUUM ACCUMULATOR CHAMBER (VACUUM CHAMBER VC11) TO STABILIZE THE VACUUM APPLIED DURING DRAINING. INSTRUMENT PERFORMANCE WAS VERIFIED AND NO FURTHER LEAKS WERE OBSERVED. THE CUSTOMER WAS CONTACTED BY BEC ON (B)(4) 2013 ABOUT THE PRINTER ERRORS MENTIONED. PER CUSTOMER, THEY HAD RESOLVED THE ISSUES RELATED TO THE PRINTER. INFORMATION ON THESE ERRORS WAS REQUESTED BUT NOT PROVIDED. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE VACUUM CHAMBER VC11. (B)(4).