Catalog Number 2426-0007 |
Device Problem
Material Separation (1562)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/11/2023 |
Event Type
malfunction
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Event Description
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It was reported that bd alaris pump module smartsite infusion set separated and leaked.The following information was received by the initial reporter with the verbatim: describe the event or problem: bd alaris pump infusion set tubing fell apart when priming set with medication.Small loss of expensive medication.-------------------------------------- what was the original intended procedure? : infusion.-------------------------------------- what problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working) ;.
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Manufacturer Narrative
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E4.The initial reporter also notified the fda on (b)(6) 2023.Medwatch report # mw4633010000-2023-8022.H3.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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The customer reported that bd alaris pump infusion set tubing fell apart when priming set with medication.No product or photo was returned by the customer.The customer complaint of separation with component - leak could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review for model 2426-0007, lot number 23059070 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 04may2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.H3 other text : see narrative below.
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Event Description
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No additional information was provided.Material #: 2426-0007, batch #: 23059070.It was reported by customer that bd alaris pump infusion set tubing fell apart when priming set with medication.Small loss of expensive medication.Verbatim: rcc received complaint via email.Email(s) attached.Describe the event or problem: bd alaris pump infusion set tubing fell apart when priming set with medication.Small loss of expensive medication.What was the original intended procedure? : infusion.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to work or stopped working).
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Search Alerts/Recalls
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