Catalog Number 2C8541 |
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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Manufacturer Narrative
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Lot #: suspected lots r22b18086 and r22b16017.Device manufacturer address 1: (b)(4).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 an unspecified quantity [at least ten (10)] clearlink system continu-flo solution sets under infused while being used with a spectrum infusion pump.The reporter stated that the pump displayed fluid was infused but the bag was still full.The unspecified antibiotic medication took 8 hours instead of 4 hours.This issue occurred during patient infusion.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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H4: the potential lot # r22b18086 was manufactured on 02/22/2022.H4: the potential lot # r22b16017 was manufactured on 02/17/2022.H10: a batch review was conducted on the suspect lot numbers and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were 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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