BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2C8541 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/12/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility submitted medwatch (b)(4).For this event.Device manufacturer address 1:(b)(4), parque industrial.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 a clearlink system continu-flo solution set leaked normal saline from the second (upper) lower hub.Nothing was connected to the hub.This issue was identified during intravenous infusion with ivf, mg and potassium.Saline was being administered at 300cc/hr.The nurse noticed that the line felt wet and there was a puddle on the arm of the chair.The set was replaced and the issue resolved.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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H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; 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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