Catalog Number 107640 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Prismaflex st150 set has been temporarily approved for use in the us under emergency use authorization eua: (b)(4) to deliver crrt to treat patients in an acute care environment during the covid-19 pandemic.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that after ending treatment with a prismaflex st150 set and upon disconnecting the patient, the end of the return line came apart with the blue outer portion of the luer lock remaining stuck on the catheter lumen.There 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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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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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