LIVANOVA DEUTSCHLAND GMBH S5 CONSOLE FOR 4 PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
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Catalog Number 48-40-00 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Air Embolism (1697)
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Event Date 05/26/2021 |
Event Type
Injury
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Manufacturer Narrative
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A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the s5 system.The incident occurred in united states.Livanova initially received the information of air in line during procedure whitout any patient impact.The case was assessed not reportable.A livanova fse was dispatched to the customer's facility, tested the s5 system and identified no deviations.Nvmem clear was then performed on each of the four pumps.Functional verification checks were performed and passed positively.The unit was put back in service.A livanova intiated 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 has been informed of a legal claims against the perfusionist of the case in which the problem occurred have been issued.Livanova is not a party in the lawsuit, but it is requested to provided documents.It looks like the plaintiff had bypass surgery on (b)(6) 2021 and when he was weaned off bypass, an adverse event occurred causing the arterial line to fill with air.Plaintiff allegedly suffered a ¿massive air embolism post revascularization and went into cardiogenic shock.
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