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); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/22/2022 |
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).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 from a hole in ¿the side of the iv (intravenous) tubing¿.This was identified in the critical care unit of the hospital during a patient infusion.The device was being used to deliver ¿iv pressor medication¿.This caused the medication to not reach 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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H4: the lot was manufactured from august 16, 2021 - august 17, 2021.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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