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Catalog Number 2C4009K |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that a large volume folfusor over infused; further described as the infusion ended much sooner, about 10 hours before the scheduled end of drug dosing, 48 hours.The device was filled correctly and the volume was with in the specific range of minimum 216 ml and maximum of 300 ml.Sodium chloride 0.9% was used as the solvent.This issue was identified during use.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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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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H4: device manufactured on august 1, 2022- august 3, 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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