A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT ONE HEMOGARD VACUTAINER PLASTIC TUBE CAP CAME OFF WHILE THE SAMPLE WAS BEING RUN ON THE COULTER LH 750 ANALYZER, CONSEQUENTLY SPILLING BLOOD INSIDE THE INSTRUMENT. THE TUBE WAS IN A CASSETTE ON THE ROCKER BED WHEN THE INCIDENT OCCURRED. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WERE NO REPORTS OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED TO THIS COMPLAINT.
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Patient 1
THE CUSTOMER CLEANED THE SPILL ACCORDING TO THE DEFINED LABORATORY PROTOCOL. AFTER CLEANING THE CUSTOMER WAS GETTING "AUTO STOP" ALARMS AND STRIPPER PLATE ERRORS. THE CUSTOMER INDICATED THAT THE TUBE WAS NOT OPENED PRIOR TO RUNNING AND THE CASSETTE WAS CORRECTLY PLACED ON THE LOADING DOCK AND ROCKER BED IN THE USUAL MANNER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND INDICATED THAT THE STRIPPER PLATE ASSEMBLY WAS DISASSEMBLED, SO THE FSE CLEANED AND REASSEMBLED IT. THE ALIGNMENT OF THE STRIPPER PLATE WITH SAMPLE TUBE WAS ALSO CHECKED WITH SATISFACTORY RESULTS. MULTIPLE PATIENT SAMPLES WERE RUN WITHOUT ANY ISSUES. THE ROOT CAUSE COULD NOT BE DETERMINED TO DATE FOR THIS EVENT. 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.