Model Number 2420-0500 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 04/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the as lvp 20d dehp 2ss cv tubing separated below the y-port connection and leaked out medication.The following information was provided by the initial reporter: "alaris tubing infusing levophed became disconnected just below y connection port.Medication dumped onto the group and patient became hypotensive.".
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Manufacturer Narrative
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H.6.Investigation: the customer reported the tubing disconnected below y-port and returned the used sample.The sample was clearly separated below the y-port and the complaint is verified.Visual inspection under the microscope found the root cause to be insufficient solvent.The solvent appears to only be at the very top of the tubing, so shallow insertion depth is also a cause.There were no other failure modes observed.A device history record review could not be performed on material #2420-0500 because a valid lot number was not provided by the customer.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 2ss cv tubing separated below the y-port connection and leaked out medication.The following information was provided by the initial reporter: "alaris tubing infusing levophed became disconnected just below y connection port.Medication dumped onto the group and patient became hypotensive.".
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Search Alerts/Recalls
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