It was reported from a customer from the us that cardiohelp used for v/a support during a lung transplant/cabg procedure.At or around 4 hours on the cardiohelp, echo/tee shows copious amount of air in the aortic root, ascending and descending aorta- nothing inter-cardiac noted.Dr.(b)(6) (performing surgeon) has concerns that the cardiohelp might have allowed air to pass through oxygenator then into the patient.The bubble detector was never trigger by air, no visible or audible air was noted throughout the run.The disposable in question is no longer available for return.Which hls set was used in requested but still pending.Additional information: bubble alarm did not activate but was active per customer, outcome was multiple strokes and eventual death, echo = echocardiogram, no cracks noted in system, cannulas appeared functional and were checked per surgeon.The affected cardiohelp will be handled under complaint id: (b)(4).Follow up information: new relevant information received on 2019-08-20.According to the perfusionist which was involved in the incident: ¿she states that this patient is not deceased, the patient is still alive but not waking up from multiple strokes.Please note the patient has not expired!¿ complaint id: (b)(4).
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