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Catalog Number 2C1008K |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The event occurred sometime between (b)(6) 2016.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 infusor had air bubbles inside of its tubing.This occurred after the device was filled with an unspecified solution using a repeater pump, after priming, and before patient use.The reporter stated that after hours of standing, the air bubbles ¿drew out¿.The device was not used on a patient.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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(b)(4).Device manufacture date: 06/10/2015 ¿ 06/11/2015.The device was received for evaluation.Since the sample was returned without the administration tube set and the flow restrictor, functional flow testing could not be performed.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.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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