The model and serial number are unknown.This information will be provided in a supplemental report if made available.Initial reporter: the hospital where the surgery took place is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the heater-cooler system 3t.It is unknown where the incident occurred.This medwatch report is being filed on behalf of livanova (b)(4).The letter from the customer did not indicate a serial number or hospital information.It is unknown if the involved device has been found to be contaminated, or if the reported infection is related to the use of the heater-cooler.Due to ongoing litigation, no further follow-up can be performed at this time.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device availability is unknown.
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Livanova (b)(4) received a letter from a patient who underwent a vessel coronary artery bypass surgery on (b)(6) 2013 and reportedly became infected with mycobacterium chimaera.It was reported that a heater-cooler system 3t was used during the procedure.The patient reported to be feeling fatigue, muscle and join pain, and weight loss.The report indicated that treatment is in progress.
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