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Model Number 383401 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
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Event Description
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The customer reported that the device provided inaccurate volume infusion.There was no patient harm reported.
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Manufacturer Narrative
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Upon further review of all available information, it was determined that this event was inadvertently reported in error as the details of the incident do not meet the criteria of a reportable malfunction or event.No further follow up reports will be submitted.
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Search Alerts/Recalls
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