Catalog Number H938737 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/03/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(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 250ml exactamix eva tpn bag had leaked.The event had occurred after the bag had been filled with an unspecified solution.It was reported the leak was located where the fill port met the bag.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection with magnification noted a leak from where the filling port meets the bag.Functional testing was performed by filling the bag with water and a leak was observed from the fill port weld.The reported issue was verified.The cause of the reported issue could not be determined.Should additional relevant information become available, a supplemental report will be submitted.
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Manufacturer Narrative
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To address this issue, the supplier has been notified of this condition.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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