Description of Event or Problem · 1
VOLUNTARY REPORT BY (B)(6). HEATER COOLER DEVICES TESTED POSITIVE (1 FOR 6 COLONIES AND ANOTHER 1 FOR 1 COLONY) OF NTM M CHIMERA. THE DEVICE WITH 6 CONFIRMED COLONIES WAS TAKEN OUT OF SERVICE AND THE DEVICE WITH ONE COLONY IS ONLY USED FOR LIFE THREATENING EMERGENCIES. DUE TO THE PUBLIC CONTROVERSY SURROUNDING, THE INFECTIONS TRACED BACK TO THE HEATER COOLER DEVICES USED DURING OPEN HEART SURGERY, WE PERFORMED TESTING OUR THREE DEVICES IN MARCH 2016. IN AUGUST 2016, WE RECEIVED NOTICE THAT TWO OF OUR THREE DEVICES TESTED WITH SMALL AMOUNTS OF M CHIMERA NTM COLONIES. THE LARGEST LOAD OF COLONIES WAS 6 IN 100ML FOR DEVICE SERIAL # (B)(4), DEVICE SERIAL # (B)(4) TESTED WITH ONE COLONY OF M CHIMERA. OUR THIRD DEVICE SERIAL # (B)(4) WAS NEGATIVE IN ALL CULTURES. WE ARE USING THE DEVICE THAT TESTED NEGATIVE FOR OUR OPEN HEART SURGERY PROGRAM. THE DEVICE WITH THE 6 COLONIES OF M CHIMERA WAS TAKEN OUT OF SERVICE. THE DEVICE WITH ONE COLONY IS ONLY TO BE USED IN LIFE THREATENING EMERGENCIES SUCH AS IN BACK UP FOR OUR ANGIOPLASTY PROGRAM. WE ARE PERFORMING MAINTENANCE AND CLEANING PROCEDURES IN ACCORDANCE WITH THE MANUFACTURER'S RECOMMENDATIONS. NO KNOWN PT INFECTIONS ASSOCIATED WITH THE USE OF ANY OUR HCD'S. TESTING DONE AT (B)(6), TEST BIO-SAMPLE # (B)(6).