Catalog Number 0450000000 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Blood Loss (2597)
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Event Date 04/16/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.(b)(4).
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Event Description
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It was reported that the console did not achieve tamponade which lead to excessive bleeding during a procedure.The procedure was completed successfully with the use of a back up device.
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Manufacturer Narrative
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The product was returned for investigation and the reported failure mode was not confirmed.Alleged failure: this pump did not appear to prime correctly.This caused excessive bleeding, and a lack of tamponade.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be user setup, pinched valve on cassette.The reported failure mode will be monitored for future reoccurrence.(b)(4).
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Event Description
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It was reported that the console did not achieve tamponade which lead to excessive bleeding during a procedure.The procedure was completed successfully with the use of a back up device.
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Search Alerts/Recalls
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