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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 03/26/2024 |
Event Type
malfunction
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Manufacturer Narrative
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E1: initial reporter phone no.- (b)(6).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 two (2) multirate large volume infusors underinfused during infusion.The expected therapy time was 48 hours, after 52 hours the device was still delivering medication.The device contained fluorouracil.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 lot was manufactured between august 31, 2023 to september 1, 2023.H11: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed, and the flow rates were found to be within the product specification.The infusor device was determined to be a conforming product.The reported condition was not verified.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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