ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TEGO® CONNECTOR; SET, ADMINISRATION, INTRAVASCULAR
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Catalog Number D1005 |
Device Problem
Disconnection (1171)
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Patient Problem
Blood Loss (2597)
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Event Date 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device is not available for investigation.Without a returned sample, the probable cause cannot be determined.The lot number is unknown, therefore, a device history review cannot be performed.If additional information becomes available a supplemental report will be submitted.
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Event Description
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A user facility mandatory medwatch (# (b)(4)) was received for an event that occurred in the pediatric intensive care unit (picu) and involved a tego needleless safety connector that ¿disconnected¿ during a ¿respiratory treatment¿ resulting in approximately 30ml of blood loss.The nurse entered the room when the circuit alarmed and found the return line in the bed.The machine was paused, the hub was scrubbed, the line was reconnected, and the therapy was restarted.The nurse practitioner and fellow were notified and arrived at the bedside.Antibiotics were ordered and a complete blood count was drawn.
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Search Alerts/Recalls
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