Catalog Number 2420-0500 |
Device Problems
Component Missing (2306); Free or Unrestricted Flow (2945)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/26/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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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Event Description
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It was reported that the alaris pump module smartsite infusion set experienced a missing component: roller clamp.The following information was provided by the initial reporter: went to prime the "bdalaris pump infusion set" and the tubing was missing a roller clamp.So, i grabbed another one and that tubing was missing a luer lock at the end.Lot is (10) 20043249 for both packages of tubing.
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Manufacturer Narrative
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Due to no photo or sample being received, the customer's complaint of misassembly / missing roller clamp could not be verified at this time.A device history record review for model 2420-0500 lot number 20043249 was performed.The search showed that a total of 34,563 units in 1 lot number was built on (b)(6) 2020.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 the alaris pump module smartsite infusion set experienced a missing component: roller clamp.The following information was provided by the initial reporter: went to prime the "bdalaris pump infusion set" and the tubing was missing a roller clamp.So, i grabbed another one and that tubing was missing a luer lock at the end.Lot is (10) 20043249 for both packages of tubing.
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Search Alerts/Recalls
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