Catalog Number 103453 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2022 |
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.
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Event Description
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It was reported that towards the end of treatment with a phoenix machine, external blood leak was observed.The line was erroneously occluded by the user and the bottom of the dialyzer burst resulting in the external blood leak.The extracorporeal circuit blood was returned to the patient.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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The device was not received for evaluation.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was not returned; 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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