Model Number 10053857 |
Device Problems
Leak/Splash (1354); Incomplete or Inadequate Connection (4037)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/23/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The initial reporter also notified the fda on 31jan2022.Medwatch report # (b)(4) a sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported while using alaris smartsite gravity set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: material #: 10053857, batch #: 20129628.Verbatim: notice dripping of medication at the filter upon starting the infusion.No medication touched patient.Filter replaced with a new one.Infusion started without any issues.
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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 filter leakage could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review for model 10053857 lot number 20129628 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 23dec2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
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Event Description
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It was reported while using alaris smartsite gravity set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: material #: 10053857, batch #: 20129628.Verbatim: notice dripping of medication at the filter upon starting the infusion.No medication touched patient.Filter replaced with a new one.Infusion started without any issues.
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Search Alerts/Recalls
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