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Catalog Number 2C1009K |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/08/2023 |
Event Type
malfunction
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Event Description
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It was reported that the fill port of a large volume infusor was broken.The issue was identified during patient infusion.The device was filled with ifosfamide 1g, mesna 5g, compound sodium chloride 190ml.The nurse used a transparent film to give external fixation and continued to observe.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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E1: initial reporter address: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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Device manufacture date: the lot was manufactured from july 7, 2022 to july 8, 2022.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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