Catalog Number 20129E |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/18/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter facility name- (b)(6) hospital.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd alaris extension set was occluded the following information was received by the initial reporter with the following verbatim: item description: tube iv ext w/ filter 1.2 mi mfg# 20129e lot# (10)23099411 qty: 1 ea description of problem: lipid filter occluded.
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Event Description
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No additional info.
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Manufacturer Narrative
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The customer reported that the set occluded.One sample model 20129e lot 23099411 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a bd primary set and primed with 85% glycerin / 15% water.An infusion run was started at a rate of one ml/hr for 24 hrs.There was no observation of fluid blockage.The customer complaint was unable to be replicated.See the attached ¿filtering out the facts: recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)¿ for additional information regarding the use of ivfe with in-line filter administration sets.Although the issue was unable to be replicated and the root cause is unknown bd is looking at opportunities to improve the filter function to alleviate this failure in the future.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 (b)(6) 2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
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Search Alerts/Recalls
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