Catalog Number IN2C1155KP |
Device Problem
Filling Problem (1233)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/30/2019 |
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 multirate infusor underinfused during a patient infusion.The expected therapy time was 46 hours.The reporter stated that after 48 hours, there was drug remaining in the device.The device had been filled with fluorouracil (5-fu).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 october 25, 2018 - october 29, 2018.H0: the device was received for evaluation.A visual inspection was performed using the naked which eye did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate testing was performed with no issues noted; rate was found within specification range.The device was found to be 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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