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Model Number 75205 |
Device Problem
Other (for use when an appropriate device code cannot be identified) (2203)
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Patient Problem
Other (for use when an appropriate patient code cannot be identified) (2200)
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Event Date 11/04/2014 |
Event Type
Other
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Event Description
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Sorin group (b)(4) received a report that, after being given 2 units of bank blood as well as a small amount of blood which was processed using the electa autotransfusion device, the patient developed renal insufficiency resulting in hemoglobinuria, anuria, acute kidney injury and hyperkalemia.After 48 hours of continuous observation, the patient was released with no permanent injury.
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Manufacturer Narrative
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The patient identifier and weight were not provided.Sorin group (b)(4) manufactures the dideco electa.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(6) received a report that, after being given 2 units of bank blood as well as a small amount of blood which was processed using the electa autotransfusion device, the patient developed renal insufficiency resulting in hemoglobinuria, anuria, acute kidney injury and hyperkalemia.After 48 hours of continuous observation, the patient was released with no permanent injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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Search Alerts/Recalls
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