ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN PRIMARY SET; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number UNKNOWN |
Device Problems
Obstruction of Flow (2423); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/01/2023 |
Event Type
malfunction
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Event Description
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The incident involved an unknown primary intravenous (iv) tubing set on an unknown date.It was reported that the rubber stopper becomes lodged inside the microclave after connecting the secondary tubing.This causes a proximal occlusion, a large amount of air to be pulled through, and the medication in the secondary line to backprime into the primary tubing.There was unknown patient involvement and unknown human harm.
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Manufacturer Narrative
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The device has been requested to be returned for evaluation; however, it has not yet been received.E1: phone extension ext.(b)(4).
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Manufacturer Narrative
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The complaint of silicone sleeve stuck down could not be confirmed by investigation since no product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review (dhr) couldn't be performed due to lot number for this complaint was unknown.
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Search Alerts/Recalls
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