Device Problems
Device Alarm System (1012); Increase in Pressure (1491)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that over the last 3-4 weeks, two intravenous pre-mixed treprostinil cassettes kept alarming the pump for high pressure.Switched to back up cassettes without any issues, and no harm to patient.There were no problems with pumps, only with the two cassettes.There was no stop in therapy.There were no side effects reported.This is a continuous infusion.The event occurred while in use with patient.There were additional devices to switch to.Infusion is life-sustaining.The event is resolved.There was no patient injury.
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Manufacturer Narrative
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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.Catalog number and udi number and pma/510k are unknown, no information provided to date.
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Event Description
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Additional information received and attached by icu medical on 22/jul/2022 via email: contact details updated.Patient details added.
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Manufacturer Narrative
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Other, other text: additional information was received.(updated b5).
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Search Alerts/Recalls
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