BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 2C8671 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
High Blood Pressure/ Hypertension (1908)
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Event Date 04/18/2022 |
Event Type
Injury
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Manufacturer Narrative
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(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 during patient infusion of levophed, phenylephrine and amiodarone with 3 units of clearlink system extension sets, an inadvertent bolus from the extension filter was observed.This resulted in the patient experiencing hypertension reported as ¿caused the blood pressure to skyrocket¿.According to the reporter, the filter emptied out on its own.No connection issues were noted and the lines were setup properly.After the "filters were removed, the patient's blood pressure "evened out".No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, a companion sample was received for evaluation.Visual inspection with the naked eye of the companion sample did not identify any abnormalities that could have contributed to the reported condition.Functional testing including clear passage and under water pressure testing were performed.The companion samples were determined to meet functional performance specification requirements.The reported condition was not verified.The cause of the condition could not be determined.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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Search Alerts/Recalls
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