Catalog Number ARC2220P |
Device Problem
Failure to Prime (1492)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/14/2015 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).(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 solution administration set was unable to prime.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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(b)(4).The device was returned for evaluation.Visual inspection did not reveal any issues.A functional underwater leak test was performed; there was flow obstruction in the assembly between the injection site and the tube.The cause was determined to be excess solvent between the injection site and the tube assembly.A capa has been opened to address this issue.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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