ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. CONECTOR TEGO¿; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number LAT-D1000 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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No product samples, videos, or photographs were provided for investigation.The lot history was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.
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Event Description
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The event involved a tego connector that the customer reported a leak of blood secretion from the venous lumen.The leak occurred 10 minutes after starting a hemodialysis session and the pump alarmed for low venous pressures.When checking the alarm it was noted there was the leak of bloody secretion.The connector was changed out for another one of the same reference and therapy continued without complications.There was patient involvement, however, no report of harm.
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Search Alerts/Recalls
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