Model Number OXY-1 CONSOLE |
Device Problems
Pumping Stopped (1503); Failure to Deliver (2338)
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Patient Problem
Respiratory Failure (2484)
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Event Date 03/08/2021 |
Event Type
Death
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Manufacturer Narrative
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The investigation is on-going at this time.Upon completion of the investigation a final report will be filed.
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Event Description
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A patient was transferred to the tertiary medical center with a covid + diagnosis and in need of intubation and escalated medical care.An oxy-1 ecmo device was placed for support and oxygenation.The system provided v-v cannulation for 15 days.During the support, on day 11, there were calls made for technical support when the screen was noted to be darkened, due the power being mistakenly shut off due to a user error.That power failure was rectified and support proceeded on the same oxy-1 system.On day 15 the oxy-1 ecmo had what was termed a system failure.The staff was then forced to provide emergency resuscitation, which failed.The patient expired.
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Manufacturer Narrative
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The investigation into the event has concluded.The oxy-1 product was tested and a root cause was unable to be determined.Team is unable to determine the cause of the system failure.The failure will be monitored and trended.
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Manufacturer Narrative
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Since previous reports filed the manufacturer has updated udi information and product return to manufacturer documentation.This is the final supplemental correction report.
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Manufacturer Narrative
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The following data has been corrected: 1) d4 - update catalog # 001-3300-011, 2) h- update medical device problem code to 1503 - pumping stopped, 3) h- update component code ¿ with 765 - controller, 4) type of reportable event changed from serious injury to death (last supplemental erroneously had serious injury, while initial report showed death).
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Search Alerts/Recalls
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