Catalog Number 2420-0500 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd alaris pump module smartsite infusion set a component was missing.There was no report of patient impact.The following information was provided by the initial reporter: alaris pump infusion set missing male luer piece that connects to patient's iv.
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H6: investigation summary: no product or photo was returned by the customer.The customer complaint of misassembly could not be verified due to the product not being returned for failure investigation.A device history record review for model 2420-0500 lot number 22073280 was performed.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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Event Description
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It was reported while using bd alaris pump module smartsite infusion set a component was missing.There was no report of patient impact.The following information was provided by the initial reporter: alaris pump infusion set missing male luer piece that connects to patient's iv.
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Search Alerts/Recalls
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