Model Number 2426-0500 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2020 |
Event Type
malfunction
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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.(b)(4).
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Event Description
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It was reported that the as lvp 20d dehp 3ss cv tubing had broken from the connector.The following information was provided by the initial reporter: "reporting another issue with product #: 2426-0500, alaris pump infusion set.On (b)(6) 2020 a nurse in our infusion unit was going to prime the iv for a patient.She opened the bd tubing and noticed right away it was broken at the y site below the pump segment.There was no patient harm or delay in care.".
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Manufacturer Narrative
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H6: investigation summary a sample was received in and the separation was immediately apparent verifying the customer's complaint.Visual inspection under microscope was performed and the root cause determined to be a shallow insertion in the junction where tubing meets y-site.A device history record review for model 2426-0500 lot number 20063383 was performed.The search showed that a total of 33,303 units in 1 lot number was built on 15jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.
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Event Description
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It was reported that the as lvp 20d dehp 3ss cv tubing had broken from the connector.The following information was provided by the initial reporter: "reporting another issue with product #: 2426-0500, alaris pump infusion set.On (b)(6) 220 a nurse in our infusion unit was going to prime the iv for a patient.She opened the bd tubing and noticed right away it was broken at the y site below the pump segment.There was no patient harm or delay in care.".
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Search Alerts/Recalls
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