Catalog Number 20129E |
Device Problems
Complete Blockage (1094); Excess Flow or Over-Infusion (1311)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/13/2023 |
Event Type
malfunction
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Event Description
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It was reported that bd alaris extension set unregulated flow the following information was received by the initial reporter with the following verbatim: item description: tube iv ext w/ filter 1.2 mi lawson# (b)(4).Mfg# 20129e lot#(10)23099411 qty: (b)(4).Description of problem: lipids were alarming with pressure limit being high.Changed filter and lipids are now running safely.
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Manufacturer Narrative
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E1: initial reporter facility name- (b)(6) specialists.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint that there was fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for model 20129e lot number 23099411 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28sep2023.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.
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Search Alerts/Recalls
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