Catalog Number H938739 |
Device Problems
Fluid/Blood Leak (1250); Hole In Material (1293)
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Patient Problem
No Patient Involvement (2645)
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Event Date 02/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The device was not returned for evaluation; therefore, a device analysis could not be completed.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 an exactamix 1000ml eva tpn bag leaked from a small hole in the seam at the top of the bag.This occurred after compounding.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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