Model Number 2420-0007 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/07/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a complaint of three sets having holes and leaking was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage could not be verified due to the product not being returned for failure investigation.A device history record review for model 2420-0007 lot number 21065450 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 104jun2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 3 bd alaris¿ pump module smartsite¿ infusion sets had holes in their tubing that caused leakage.The following information was provided by the initial reporter: "i got a call from our ob department and the alaris pump back check valve set 2 smartsite y-site, bd#2420-0007 are leaking." "we have had 3 primary tubing sets in the last few days that have had holes in them and were causing leaks.They all were from the same lot number (10)21065450.One of the three also had a damaged roller clamp.".
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Search Alerts/Recalls
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