BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2C8541 |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/18/2022 |
Event Type
malfunction
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Event Description
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It was reported that an underinfusion of medication occurred while using an unspecified quantity of clearlink system continu-flo solution sets.The expected therapy time was 4 hours; however, the therapy took almost 8 hours to deliver the medication.It was also observed that the medication bag still contained medication that had not been delivered to the patient after the expected therapy time was completed.This issue occurred during patient infusion.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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Lot #: suspected lots r22b18086 and r22b16017.Device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H4: the suspected lot number r22b16017 was manufactured on february 17, 2022 the suspected lot number r22b18086 was manufactured on february 22, 2022 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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