Catalog Number 4122201 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/26/2023 |
Event Type
malfunction
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Event Description
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The customer reported to terumo bct customer support that during a therapeutic plasma exchange (tpe) procedure there was a "cells were detected in plasma line from centrifuge" alarm and the operator noticed that the plasma lines were not fixed to the cassette.There was no reported injury and not medical intervention for this event.The patient id and age are unknown at this time.The collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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Investigation: reported calculated final fluid balance was 103%.The device history records (dhr) were reviewed for this lot. there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process, a follow-up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: reported calculated final fluid balance was 103%.The device history records (dhr) were reviewed for this lot. there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was confirmed that there was no concern for ac overinfusion for this event.No further reporting will be provided as this does not represent a reportable event.
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Event Description
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The customer reported to terumo bct customer support that during a therapeutic plasma exchange (tpe) procedure there was a "cells were detected in plasma line from centrifuge" alarm and the operator noticed that the plasma lines were not fixed to the cassette.There was no reported injury and not medical intervention for this event.The patient id and age are unknown at this time.The collection set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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