Catalog 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 03/07/2024 |
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 pump module smartsite infusion set bulges the following information was received by the initial reporter with the following verbatim: reported issue: alaris pump alarming.Rn went to check pump error, opened the large volume channel door and found bd alaris pump segment ballooning (tubing aneurysm) along the pump segment of the infusion tubing.Rn changed the tubing with no untoward incidents.
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Event Description
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No additional info.
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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint that there is ballooning in the silicone segment could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.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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