Model Number 40000-07T |
Device Problems
Separation Failure (2547); Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/18/2021 |
Event Type
malfunction
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Event Description
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It was reported that the bd alaris¿ texium¿ secondary set tubing separated from below the drip chamber.The following information was provided by the initial reporter: "tubing came apart below drip chamber".
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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H.6.Investigation: the customer reported the tubing came apart at the drip chamber and returned one used sample of material #(b)(4).The sample was clearly separated below the drip chamber and the complaint is verified.A device history record review for model 40000-07t lot number 20095693 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause is determined to be insufficient solvent.Our manufacturing team is aware of the issue and has funded a project, capa#3974230, to make the necessary changes.The solvent dispenser on the drip chamber assembly for multiple part numbers was found to have an issue with the screw depth specification and the issue is being addressed.A complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of separation other component - no leak with lot #20095693 regarding item #40000-07t.
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Event Description
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It was reported that the bd alaris¿ texium¿ secondary set tubing separated from below the drip chamber.The following information was provided by the initial reporter: "tubing came apart below drip chamber".
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Search Alerts/Recalls
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