D
Patient 1
A CUSTOMER RECEIVED AN INJURY WHEN AN OPEN BOTTLE OF NAOH-D FELL FROM A TABLE AND SPLASHED ON HER FACE. THE EMPLOYEE RINSED HER FACE WITH WATER IMMEDIATELY AND WAS TREATED BY THE SAFETY PERSON OF THE HOSPITAL. THIS TREATMENT INCLUDED MORE WASHING AND THEN TREATMENT WITH BURN OINTMENT. THE EMPLOYEE IS NOW ON SICK LEAVE WITH BURN WOUNDS BETWEEN FIRST AND SECOND DEGREE. THERE WAS NO DAMAGE TO THE EMPLOYEE'S EYES ALTHOUGH THE EMPLOYEE WORE NO SAFETY GOGGLES. UPON FOLLOW UP, IT WAS CONFIRMED THE EMPLOYEE WAS "OK". THE CUSTOMER WAS REFILLING THE BOTTLE AT THE TIME OF THE EVENT BECAUSE THE SOFTWARE OF THE ANALYZER, COBAS 6000 C501 ANALYZER SERIAL NUMBER (B)(4), INDICATED THE BOTTLE WAS EMPTY. REFILLING OF REAGENT BOTTLES IS NOT RECOMMENDED. THE CUSTOMER ALLEGED AN ISSUE WITH THE SOFTWARE, STATING THE SYSTEM IS ALERTING THEM THAT THE VOLUME OF THE REAGENT IS ZERO, OR EMPTY, WHEN THERE IS STILL REAGENT LEFT IN THE BOTTLE. THIS ISSUE WAS PREVIOUSLY INVESTIGATED AND IT WAS DETERMINED THE SYSTEM IS FUNCTIONING PROPERLY. THE SYSTEM ALERTS THE USER WHEN THE USABLE VOLUME FOR THE PRODUCT HAS BEEN REACHED. IT IS EXPECTED THERE WILL BE 200 TO 300 ML OF LIQUID LEFT IN THE BOTTLE. REFILLING OF THIS BOTTLE IS NOT RECOMMENDED. THE CUSTOMER ALSO BELIEVED THAT AN ADDITIONAL WARNING SENTENCE SHOULD BE INCLUDED ON THE BOTTLE ITSELF. THE LABELING WAS INVESTIGATED AND DETERMINED TO BE IN COMPLIANCE WITH LABELING REGULATIONS. THE OPERATOR'S MANUAL FOR THE ANALYZER AND THE PACKAGE INSERT FOR NAOH-D PROVIDE SAFETY WARNINGS FOR EXCHANGE OF CELL WASH BOTTLES. THE LABELING ALSO INCLUDES A PROTECTIVE EQUIPMENT WARNING AND HAZARD LABELING. THE DETERGENT COMPARTMENT ON THE ANALYZER ALSO INCLUDES A LABEL WITH A PROTECTIVE EQUIPMENT WARNING.