(b)(4).The reported complaint was confirmed with the manufacturer's technical services.Per the user facility's biomedical technician, the analog board of the heater cooler was calibrated resolving the issue.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the service alarm on the unit turned on.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.Per clinical review: during a cpb procedure on (b)(6) 2018, the perfusion team noticed that the service alarm was turning on.This alarm condition was not affecting the units ability to cool or warm the patient.The alarm condition was not attributed to a leak within the system.The patient was cooled and warmed appropriately with the device during the procedure, therefore the perfusionist chose to not exchange the unit at that time.The heater coolers at the user facility are maintained and cleaned per manufacturers recommendations.The incident did not delay the continuation of the surgical procedure.There was no blood loss or harm associated with the event.
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