BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2H7462 |
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 11/30/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter address: (b)(4).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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Event Description
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It was reported that a clearlink duo-vent secondary medication set leaked at the air intake opening clip during an unspecified process step.Chemotherapy leaked on the pole to the ground.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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