Death of a patient.Customer reported the patient died following an on (b)(6) 2017 surgery at (b)(6) hospital.Apparently, the patient developed disseminated intravascular coagulation (dic) the patient's blood became contaminated (with what is currently unknown) and, upon the reinfusion of cell saver material, the patient expired.The reported issue will be noted but could not be reproduced.Fresenius kabi tried to obtain information form the customer on multiple occasions.Very little information was received.The involved device could not be identified, therefore no data about device service history or service activities after the incident were available.The autopsy report was analysed with a consultant clinical expert.According to the consultant clinical expert, the autopsy report does not contain sufficient information to make a precise statement regarding a potential device related problem.No root cause could be identified with the received information.
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