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Catalog Number 4824062 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Event Description
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The customer reported that during an apheresis platelet procedure on a trima device, two air bubbles were observed.One near the needle and one 10 inches up the return line, both air bubbles measuring approximately 0.5 cm in length.Per the customer, no air was infused to the donor.All leur connections were tight and there was no clotting in the channel or in the return reservoir.They said the blood diversion pouch was not inflated with air, there were no alarms, the donor was connected prior to ac prime, and there was no air being drawn in through the ac line or filter.No medical intervention was reported, and the donor was reported to be stable.Customer declined to provide donor id.
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Manufacturer Narrative
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Investigation: one used trima set containing blood was returned for investigation.It was noted that blood had circulated throughout the set, the platelet bag and the donor needle were removed.The disposable set was visually evaluated for any mis-assembly, leak location, or defect that could have contributed to the reported incident with no anomalies observed.All pressure sensors were inspected and determined to be functioning properly.Gravity was used to manipulate fluid throughout the set and no fluid flow or line obstruction issues were noted.All clamps were checked and were functional.No bond gaps were observed.Investigation is in process, a follow-up report will be provided.
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Search Alerts/Recalls
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