Catalog Number 2C4063K |
Device Problem
Filling Problem (1233)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/24/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter facility name: (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 a large volume folfusor underinfused.The device had been filled with 13.5g piperacillin/tazobactam in 230ml 0.9% sodium chloride.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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H10: the device was received containing 185 ml of fluid in the bladder.Visual inspection using the naked eye did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed and the results were within the product specification range.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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