Catalog Number 2C8519 |
Device Problems
Disconnection (1171); Fluid/Blood Leak (1250); Cut In Material (2454)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/03/2018 |
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 continu-flo solution set separated at the y-connection and caused a break in the line.As a result, fluid leaked out and the patient¿s blood flowed back through the line; the patient did get wet from leaking solution.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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The actual device was not available; however, a photograph of the sample was provided for evaluation.Inspection of the sample photograph identified that the tubing had separated from the y-site.The reported condition was verified.The cause of the reported 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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