COULTER® LH 750 SLIDEMAKER
Received Mar 27, 2013 · Event occurred Feb 26, 2013
Report 1061932-2013-00512 · MDR key 3024447
Device
Generic name
Spinner, Slide, Automated
Manufacturer
Beckman CoulterModel number
NACatalog number
6605633
Lot number
NA
Product problems
- Fluid/Blood Leak
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
THE AFFILIATE REPORTED THE CUSTOMER ALLEGED FLUID DETECTOR (FD) 6 ERRORS AND APPROXIMATELY FIVE MILLILITERS OF CLEAR FLUID LEAKED WITHIN THE INSTRUMENT FROM THE RIGHT SIDE TRAY INVOLVING THE COULTER LH 750 SLIDEMAKER. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF PROTECTIVE GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. NO ERRONEOUS PATIENT RESULTS WERE GENERATED. THERE WAS NO PATIENT IMPACT. THE LABORATORY HAS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.
Additional Manufacturer Narrative
THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE PROBE RINSE SUPPLY LINE WAS ROUTED THROUGH PINCH VALVE VL20 INSTEAD OF PINCH VALVE VL19. THE FSE REROUTED THE TUBING THROUGH THE CORRECT PINCH VALVE AND RESOLVED THE FLUID LEAK ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).