Catalog Number 2C6750H |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/01/2017 |
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 an interlink blood set leaked.During a blood transfusion, there was blood leakage due to a rupture in the ¿y¿ before the filter chamber.It was confirmed the blood leak was observed from the blood transfusion and not from the patient.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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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 received 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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Search Alerts/Recalls
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