Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.Prismaflex st150 set c has been temporarily approved for use in the us under emergency use authorization (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.
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Event Description
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It was reported that during treatment with one unit of prismaflex st150 set, "the access line accidentally became disconnected from the catheter causing air to enter" the extracorporeal circuit (ec).The treatment was ended without the ec blood being returned to the patient.Here was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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