Model Number 2426-0007 |
Device Problem
Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/31/2023 |
Event Type
malfunction
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 22109386.Medical device expiration date: 21 oct 2025.Device manufacture date: 20 oct 2022.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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Event Description
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It was reported while using bd alaris pump module smartsite infusion set there was air in the lines.There was no report of patient impact.The following information was provided by the initial reporter: team has experienced issues with air being in the lines.Two lots have been identified.
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Event Description
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It was reported while using bd alaris pump module smartsite infusion set there was air in the lines.There was no report of patient impact.The following information was provided by the initial reporter: team has experienced issues with air being in the lines.Two lots have been identified.
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Manufacturer Narrative
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H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that the tubing has had air in the lines could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0007 and lot number 22109386 was performed.A device history record review for model 2426-0007 and lot number 22099330 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set of lot.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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