ECOLAB ORS FLUID WARMING SYSTEM

Additional Manufacturer Narrative

THE ORS-2066R IRRIGATION SOLUTION WARMER, SERIAL NUMBER (B)(4) WAS RETURNED FOR EVALUATION. AFTER THE UNIT WAS EVALUATED; THE UNIT WAS SET TO 110 DEGREES AND THE UNIT'S ACTUAL READING WAS 109.6 DEGREES. THE UNIT WAS TESTED ON 11/12/2014 FROM 8:00 AM TO 3:00 PM. THIS UNIT HEATED WITHIN SPECIFICATION. THE DHR REVIEW WAS PERFORMED BY MFG-ONE (ECOLAB'S CONTRACTOR); PER THEIR REVIEW THIS UNIT MET SPECIFICATIONS PRIOR TO SHIPMENT. AS REQUESTED, BIOMED PERFORMED AN ON-SITE TEST. BIOMED EMPLOYEES DRAPED THE WARMER AND USED APPROX. 1500CC OF WATER TO WARM. THE TEMP SETTING WAS AT 110 DEGREES, THE WARMER WARMED TO 110 DEGREES AND THEN STAYED AT 110 DEGREES. THE UNIT PERFORMED WITHIN SPECIFICATION AND TESTERS WERE UNABLE TO RULE OUT THE POSSIBILITY OF OPERATOR'S MISUSE. AT THIS TIME, ECOLAB-MICROTEK UNABLE TO RULE OUT THE POSSIBILITY OF OPERATOR'S MISUSE AS A CONTRIBUTOR DUE TO THE UNIT AS INTENDED WHEN IT TESTED. THE RETURNED UNIT WAS CLEANED AND RETURNED TO INVENTORY. THERE IS NO FURTHER ACTIONS WILL TAKE PLACE AT THIS TIME AS THE UNIT HAS BEEN SERVICED, TESTED, AND RETURNED TO INVENTORY.

Description of Event or Problem

ECOLAB-MICROTEK BECAME AWARE OF THE EVENT ON (B)(6) 2014. DURING BREAST MASTECTOMY PROCEDURE THE SURGEON DISCOVERED THAT THE UNIT WAS OVERHEATING. THE UNIT WAS SET AT 110 DEGREES, WHEN TESTED THE UNIT REACHED A TEMPERATURE OF 121 DEGREES - ELEVEN DEGREES OVER THE SET POINT. THE CUSTOMER REPORTED THAT THE PATIENT WAS BURNED (SMALL BURNED); ADDITIONAL MINIMAL TREATMENT WITH BACITRACIN OINTMENT WAS GIVEN TO THE PATIENT. THE INCIDENT OCCURRED ON (B)(6) 2014. THE OPERATING ROOM MANAGER FOR PLASTIC AND RE-CONSTRUCTIVE SURGERY, STATED THAT THE SURGEON REQUESTED THE IRRIGATION FLUID TO BE HOTTER, AND RAISED THE TEMPERATURE. SHE INDICATED THAT HE WANTED THE TEMPERATURE TO BE 120 DEGREES. THE SURGEON HAS SINCE BEEN EDUCATED AS TO THE CORRECT TEMPERATURE FOR THIS DEVICE. THE ORIGINAL DRAPE USED DURING THE PROCEDURE IN QUESTION WAS DISCARDED.