BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number AMC9668 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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It was reported that a continu-flo solution set separated between two components.The issue was further described as, ¿the set got detach, leaving it in two parts (components separated)¿.This occurred during induction of general anesthesia.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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Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H11: the actual device was received for evaluation.The sample underwent visual inspection which identified the tube was separated from the y-connector (clearlink); no solvent residue was present on the tube or around the inner perimeter of the y-connector.A dimensional analysis was performed and the tube was conforming per specifications.The reported condition was verified.The cause of the condition was determined to be related to manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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