Catalog Number 20128E |
Device Problem
Defective Component (2292)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/23/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 smartsite extension set was damaged the following information was received by the initial reporter with the following verbatim: it was reported by customer that blown filters, negative outcome is that we have to replace the filter.Potential harm is air embolism if they did not replace the filter.Negative outcome is that we have to replace the filter.Potential harm is air embolism if we did not replace the filter.Lot number.(10)23099145 3 filters (10)23079197 1 filter.
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Manufacturer Narrative
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Dhr only.No product or photo was returned by the customer.The customer complaint of blown filters could not be verified due to the product not being returned for failure investigation.Device history record review for model 20128e lot number 23099145 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 13sep2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.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.
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Event Description
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No additional information was provided.
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Search Alerts/Recalls
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