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Catalog Number 2C2009K |
Device Problem
No Flow (2991)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that there was no fluid flow through a large volume infusor.This issue was further described as, ¿low flow rate or even to be no flow in the tubing¿.This issue occurred while filling the device before use with a patient.There was no patient involvement.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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H4: the lot was manufactured between june 28, 2023 - june 30, 2023 h10: the actual device was received for evaluation containing 152ml of fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.After the luer cap was removed, evidence of continuous flow of fluid was observed flowing out of the distal luer.A functional flow rate test was performed and the flow rates were found to be within the product specification range.The infusor unit was determined 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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