ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 107" (272CM) APPX 8.7 ML, TRANSF SET W/DUAL CHK VALVE, MICROCLAVE® CLR, ROT LUER; STOPCOCK, I.V. SET
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Model Number MC33892 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/27/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Although the device was requested to be returned for evaluation, it has not been received.Additional contact names/information at the user facility were provided as follows: (b)(6).Uf/importer report# (b)(4).
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Event Description
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The event involved a 107" (272 cm) appx 8.7 ml, transfer set w/dual check valve, microclave® clear, rotating luer.A medsun mandatory and voluntary medwatch report form (b)(4) was received that stated that the "closed medication administration infusion set being utilized on unit for medication administration with flush to follow for infusion via central lines." the medwatch report further states that "normal saline bag attached to set, intended to allow for flush fluid to be pulled into syringe via one way valve has inadvertently infused into the patient.Volume of 90-180ml additional administered over several hours that was not intended." the customer further clarified that the reported event occurred in the hospital.Although there was patient involvement, there was no medical intervention required and no human harm.This captures the first of two events reported.
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Manufacturer Narrative
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No product samples, videos, or photographs were returned for investigation.The device history record (dhr) was reviewed and there were no relevant non-conformances identified that would have contributed to the reported complaint.The complaint cannot be confirmed based on the information that has been provided.
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Search Alerts/Recalls
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