The model and serial number are unknown, and the unique identifier (udi) number could not be determined.This information will be provided in a supplemental report if made available.As the model number is unknown, the 510(k) number could not be determined.This information will be provided in a supplemental report if made available.As the serial number was not provided, 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.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication, livanova (b)(4) learned that seven heater-cooler devices were used between 2011 until 2012.It could not be determined which device was used during the relevant surgeries.The customer reported that all heater-cooler systems are currently in storage and are not in use, with the last unit removed from service in mid-2016.During the surgeries the device was placed inside the operating theatre as far as possible from the patient with the exhaust air directed away from the surgery-field.The facility stated that microbiological testing has been performed from 2015 onward, and atypical mycobacterium has been identified in all heater-cooler devices.The samples were reportedly taken from the drain before performing a cleaning cycle.The customer stated that cleaning protocols from 2011 are no longer available.More current cleaning protocols have not been provided by the facility.The investigation is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Livanova (b)(4) received a report that a patient died of multi-organ failure on the second post-operative day following surgery of an aneurysm spurium in the area of the aorta root.The report indicated that the patient had undergone an aortic valve replacement in (b)(6) 2011, a re-operation of cerebral and coronary embolisms in thrombogenic arthroplasty with aortic valve endocarditis in (b)(6) 2012, and re-operation of an aneurysm spurium in the area of the aorta root with suspected endocarditis in (b)(6) 2017.The procedures in 2011 and 2012 involved the use of a heater-cooler system 3t.Diagnostics performed on resected aortic valve septum and ring material identified atypical mycobacteria in the patient.
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