BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2C8541 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The user facility submitted medwatch (b)(4) for this event.(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.During a chemo infusion (a bag of cisplatin, cytoxan and etoposide), the patient noticed their gown was wet.Upon further inspection, "the distal end of the port tubing noticed to have a cracked that leaked when flushed with saline".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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