Catalog Number HS-008-B |
Device Problem
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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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 became disconnected from the distal end of the cassette." device operator was a registered nurse.Medication infused was 5fu.A patient was involved but not harmed.The contract manufacturer of the affected device is (b)(4).
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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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Manufacturer Narrative
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A service provider of infutronix provided the evaluation report for the affected administration set on 11/01/2021.Visual inspection confirmed that the tubing connector on the distal end of the cassette module was snapped and broken.The tubing was completely separated from the cassette.The reported issue was confirmed.
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Event Description
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This is a follow-up for the initially filed mdr 3011581906-2021-00075.
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Search Alerts/Recalls
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