Catalog Number HS-008-B |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Infutronix is waiting for the device to be returned for evaluation.
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Event Description
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On (b)(6) 2021, infutronix received a complaint from an end user: "an administration set model hs-008-b lot 2008004 was leaking during an infusion, there was so much of a leak that the area of the leak is uncertain." device operator was a registered nurse.Medication infused was 5fu.A patient was involved but not harmed.On (b)(6) 2021, infutronix received additional information from the end user: the set was disconnected from the cassette.The contract manufacturer of the affected device (b)(4).
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Event Description
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This is a follow-up for the initially filed mdr.
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Manufacturer Narrative
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A service provider of infutronix provided the evaluation report for the affected administration set on 11/01/2021.During the testing, the affected device had no leaking issue.Therefore, the reported issue was not confirmed.
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Search Alerts/Recalls
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