Catalog Number 955596 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/30/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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.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 during treatment with a prismaflex st150, the heparin line was became disconnected from the multi connector (access) and resulted in a blood leak.The amount of blood loss was not reported.There was no 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 actual device was not available; however, a photograph of the sample was provided for evaluation.The visual inspection of the provided picture showed that the anticoagulant line was disconnected from the multi-connector 4 ways.The reported condition was verified.The cause was supplier related.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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