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Catalog Number 2C1009K |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/13/2023 |
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 large volume infusor did not flow during patient infusion.The reporter stated that the remaining 15ml liquid could not enter, and the indwelling needle was flushed to find that the indwelling needle was not blocked.The device was filled with 160 ml of 0.9% normal saline and 105mg of endostar.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 from november 01, 2022 to november 03, 2022.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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