Device evaluation summary: the reported issue that during blood collection the centrifuge bypassed the blood collection reservoir and clean blood was sent to waste bag was verified during service.Upon checking error logs, the service technician found out two errors prompted: vacuum system failed and microprocessor failed.The fluid trap orientation was incorrect causing pressure abnormality thus vacuum system failed.The service technician checked the level sensor values within the specs, since this issue usually is associated with optic sensor.They were unable to confirm the fault, as preemptive action cable assembly level sensor was replaced.The service technician correctly reinstalled the fluid trap, calibrated it and demonstrated to the biomed the proper way to do it.Preventive maintenance was performed per specifications.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Medtronic received information that during use of an autologiq instrument, it was reported that during blood collection, the centrifuge bypassed the blood collection reservoir and clean blood was sent to waste bag.The use of the instrument was unspecified.There was no adverse patient effect associated with this event.
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