Model Number 3620-100 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/25/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A follow up report will be submitted upon completion of the investigation into this event.
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Event Description
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Customer has complained that tubing is kinked since packaging has been changed.Patients are being transferred from theatre to intensive care unit (icu) and drains are kinking.
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Manufacturer Narrative
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Analysis: the oasis chest drains in question were evaluated to determine the cause of the complaint.Upon review of the returned tube sets there was one kink in the same location on every tubing set evaluated.To determine if the kink in the tubing prohibited flow each tubing set was tested per test procedure.The test procedure was created and derived based on the requirements set forth in iso standard bs en iso 10079-3 2014.The results of this testing indicate that even with the kink in the tubing the airflow met the procedural requirements of 7.5 slpm.The lowest value seen was 27.5 slpm.This far exceeds the procedural requirement.To date there have been no other complaints from around the world.Except from the two institutions in australia.There have been over (b)(4) produced since this change was implemented in february of 2019.Summary/conclusion: based on the results of the investigation atrium medical corporation cannot conclude that the patient tube set kinking creates a patient risk.
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Search Alerts/Recalls
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