COULTER® LH 750 SLIDEMAKER

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK OF APPROXIMATELY 30 TO 50 ML OF DILUTED RED FLUID UNDER THE PROBE OF A COULTER LH 750 SLIDEMAKER. PER CUSTOMER, THEY WERE GETTING "PROBE NOT DOWN" ERRORS. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT AND GLOVES 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 CONFIRMED THE LEAK UNDER THE PROBE OF THE SLIDEMAKER AND NOTED THAT THE LEAK WAS COMING FROM THE RINSE BLOCK BEING OUT OF POSITION. AS A RESULT THE FLUID FROM THE PROBE WAS NOT DRAINING AND LEAKING INTO THE DRIP TRAY IN THE BOTTOM OF THE SLIDEMAKER. FSE CLEANED UP THE LEAK AND REPOSITIONED THE RINSE BLOCK WHICH RESOLVED THE LEAK. FSE THEN CONFIRMED THE "PROBE NOT DOWN" ERRORS. FSE OBSERVED THAT THE AIR CYLINDER FOR THE DISPENSE PROBE WAS NOT MOVING SMOOTHLY AND REPLACED THE AIR CYLINDER AFTER WHICH THE DISPENSE PROBE WAS MOVING FREELY. FSE ALSO CONFIRMED ANOTHER LEAK UNDER THE TRANSFERRING ROD OF THE SLIDEMAKER WHICH WAS COMING FROM QUICK DISCONNECT (QD) 8 THAT CONNECTS AIR/FLUID LINES FROM THE SLIDEMAKER TO THE ANALYTICAL STATION OF THE INSTRUMENT. FSE REPLACED QD 8 WHICH RESOLVED THE LEAK. THE SLIDEMAKER WAS TESTED BY MAKING SLIDES. NO FURTHER LEAKS OR ERRORS WERE OBSERVED. THE CAUSE OF THE LEAK MAY BE ATTRIBUTED TO THE MISALIGNMENT OF THE PROBE RINSE BLOCK, DEFECTIVE AIR CYLINDER AND THE QD 8 CONNECTOR. THE INSTRUMENT ALERTED THE CUSTOMER OF INSTRUMENT ISSUES. (B)(4).