Model Number 2426-0007 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.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 the tubing was damaged.This occurred 413 times.There was no report of patient impact.The following information was provided by the initial reporter: hospital had 413 each with bad tubing.They attempted to utilize this tubing set but had errors.
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Manufacturer Narrative
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Investigation summary: a complaint of tubing being bad was received from the customer.No product or photo was returned by the customer.The customer complaint of tubing defective/ damage could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0007 lot number 22059104 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 the tubing was damaged.This occurred 413 times.There was no report of patient impact.The following information was provided by the initial reporter: hospital had 413 each with bad tubing.They attempted to utilize this tubing set but had errors.
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Search Alerts/Recalls
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