LIVANOVA DEUTSCHLAND AORTIC ARCH CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
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Model Number RT-xxxxx |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Excessive Tear Production (2235)
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Event Date 03/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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During follow-up communication with the customer, livanova learned that the device was not saved for return and was inadvertently discarded due to the distressed situation.The customer reported that there did not appear to be anything physically wrong with the device that might have caused the tear.The surgeon was able to repair the damaged ivc without additional harm to the patient.The surgeon was reportedly unsure how the tear could have occurred and suggested that it may have become stuck on the ivc somehow.At this time, it is unclear whether or not there was a malfunction of the device or if the cannula contributed to the patient injury in any way.At this time, not other similar events have been reported against this catalog or lot number.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device discarded by customer.
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Event Description
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Livanova received a report that the pericardium filled with dark blood and a tear was noticed in the inferior vena cave following decannulation of the aortic arch cannula during a procedure.The patient reportedly lost 250ml of blood and required a primary surgical repair of the tear.On march 26, 2018, livanova received a user medwatch report (mw5075826) related to this issue.
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Search Alerts/Recalls
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