Catalog Number H938740 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/24/2018 |
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 2000ml exactamix eva tpn bag was leaking near the administration port.This occurred prior to use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Additional information : the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed and revealed a leak at the spike port cap from the base of the spike port tubing.The reported problem was verified.The cause of the condition could not be determined.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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