SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET; INTRAVASCULAR ADMINISTRATION SET
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Catalog Number 2420-0007 |
Device Problems
Complete Blockage (1094); Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.The customer's address is unknown.Maryland, usa has been used as a placeholder based on the reported phone area code.Fda notified?: the initial reporter also notified the fda via medwatch # mw5111187.Device manufacture date: unknown.Investigation summary: the customer complaint of tubing kinked could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2420-0007 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set had a kink in the tubing within the pump channel, preventing the medication from priming through it.The following information was provided by the initial reporter: "pressors requirements kept increasing with low bp despite levophed infusing via alaris pump.Changed iv sites, no change in bp, changed iv tubing.Bp normalizing.Upon inspection of iv tubing, it is noticed there is a kink in the tubing within the pump channel.The medication was not priming through the tubing even though the clamp was open.".
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