Medtronic received information through a post market clinical follow-up (pmcf) survey that following use of the centrifugal pumps at an unspecified time, had the following reported events: fever, allergic reaction, acute systemic suspected ethylene oxide (eto: sterilization gas).During this type of procedure there are multiple devices/instruments that may have been sterilized using eto gas, without further information we are unable to confirm if the pump was the cause of the reported reaction.Respondent says the centrifugal pump performed as expected.Facility, initial reporter, lot numbers and event date were not provided as part of this post market clinical follow-up (pmcf) survey.
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