Model Number 560BC |
Device Problem
Pumping Stopped (1503)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2018 |
Event Type
Injury
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Manufacturer Narrative
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The bio-console instrument was returned and the reported flow issue was verified during service.Upon review of the event log, medtronic service found an error code 68 (loss of communication from base to the user interface) was logged just prior to the unit shutting down and turning back on.Based on the event log, medtronic service were unable to determine if the unit shut down and rebooted by itself or if the customer had initiated.Medtronic service was unable to duplicate the reported problem during testing at the service depot.The system controller module was replaced as a precautionary measure.Functional testing was performed per specifications with no issues noted.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during use, the bio-console 560 instrument's pump stopped flowing.The patient was on pump at the time and was sustained using the hand crank.The flow stopped after 1hr41mins on bypass.The surgery was a cabg case.The distal anastomosis were complete and the aortic cross clamp had been removed.The perfusionist noticed the venous reservoir volume was increasing and used a tubing clamp to partially occlude the venous line.The perfusionist saw the 560 display panel flashing for approximately 5-8 seconds and then go black.The perfusionist was aware that there was no forward flow at the time as the patient's pressure was very low and the venous reservoir was filling up.She believed there to be no rpm at this time.The perfusionist did not look at the display on the base unit at this time.The instrument was successfully changed out with a backup and there was no resulting adverse patient effect.
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Manufacturer Narrative
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Additional information was received that the customer did cycle the power at one point during the incident.The root cause of this occurrence is undetermined.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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