Model Number 5140-8500 |
Device Problems
Pumping Stopped (1503); Unexpected Shutdown (4019)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)
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Event Date 03/21/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Cardiacassist inc.Manufactures the escort controller.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
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Event Description
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Livanova received report that the escort controller was warm to touch and shut off during ecmo support.Acute hypoxia and hypotension were observed on the patient.The controller was switched to lifesparc and oxygenators were replaced.
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Manufacturer Narrative
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H10: the sn provided in the initial report was incorrect.The serial number of the involved device is still unknown despite requested several times.However, dhr review for all escort controllers installed at facility was performed and did not reveal any deviations or non-conformities relevant to the reported issue.Based on the current level of information the most likely root cause of the event are the following: critical failure of the controller leading to a pump stop; presence of clots/thrombus on the impeller/in the upper housing that led to higher current demand from the controller leading to shut down.
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Event Description
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See initial report.
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Search Alerts/Recalls
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