Patient information was not provided.The date of event has not been provided yet.If this information is provided it will be provided in a supplemental report.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate but he could not reproduce the reported failure.He tested the unit and it was working within specifications.However, under customer request, a new device was installed.Through follow-up communication with the technician in charge, livanova (b)(4) learned that the patient did suffer a stroke during the surgery.It is unclear as to whether the incident could be or not a contributing factor of the stroke.Patient was transferred from icu and is recovering from the negative symptoms.The serial read-out of the pump has been collected and the affected device was requested back to the manufacturer site for a detailed investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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