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Catalog Number 2C9961KP |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a multirate large volume infusor underinfused during infusion.After the expected therapy time was complete, it was observed that the infusion had not finished and therefore was lfor for three more hours to finish the medication delivery.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The lot was manufactured between august 31, 2023 and september 1, 2023.The actual device was received for evaluation.A visual inspection was performed which did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed, and results were within the product specification range.The reported condition was not verified.The device was determined to be conforming product.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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