Model Number 8F PH.I.S.I.O. |
Device Problem
Pressure Problem (3012)
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Patient Problem
Neurological Deficit/Dysfunction (1982)
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Event Date 02/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The age of the device was calculated as the time elapsed between device sterilization and the date of the event.(b)(4).The involved device has been requested for return to sorin group (b)(4) for 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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Sorin group (b)(4) has received a report that during a procedure, a sudden drop of blood flow was observed.The medical team elected to change-out the oxygenator.On (b)(6) 2019, livanova was informed that after a few days of induced coma, patient presented light neurological injury and that the change-out lasted nearly 5 minutes.
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Manufacturer Narrative
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Sorin group italia manufactures the inspire 8f hollow fiber oxygenator with integrated arterial filter and hardshell.The incident occurred in (b)(6).Per exemption number e2016005, sorin group italia s.R.L.Is submitting the report for both sorin group italia s.R.L (manufacturer) and livanova usa., inc.(importer).The involved device has been returned to the manufacturer and submitted to gamma ray decontamination prior the inspection.The visual inspection found no defects nor non-conformities.No specific corrective action has been identified at the present date.Livanova will keep monitoring the market for similar events.
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Event Description
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See initial report.
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Search Alerts/Recalls
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