BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2C8541 |
Device Problems
Fluid/Blood Leak (1250); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that a clearlink system continu-flo solution set leaked intravenous fluid and blood from the second (middle) valve.The luer-activated surface (white stopper) of the valve was depressed, which allowed the fluid to leak through.This issue was identified during use.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 user facility submitted medwatch: (b)(4) for this event.G1: device manufacturer address 1: 600 mts.Oeste de entrada, principal ave.Las americas, parque industrial.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H10: the device was not returned and the lot number is unknown; 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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