ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5 GANG 4-WAY NANOCLAVE STOPCOCK W/BASEPLATE, ROTATING LUER; STOPCOCK, I.V. SET
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Catalog Number AC205 |
Device Problem
Material Separation (1562)
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Patient Problems
No Consequences Or Impact To Patient (2199); Underdose (2542)
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Event Date 07/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The device has been received.Investigation is not yet complete.
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Event Description
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The event involves an ac205, 5 gang 4-way nanoclave® stopcock w/baseplate, rotating luer that the customer reported the multiple luer lock connections broke off after a coronary artery bypass graft.The customer mentioned that one of these ports had epinephrine infusing which negatively impacted the patient after the failure of the luer lock and the patient was stabilized.There was patient involvement with an unspecified adverse event and unspecified patient harm along with a delay in therapy; however, no additional information was provided.
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Manufacturer Narrative
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H10: one (1) used list # ac205, 5 gang 4-way nanoclave¿ stopcock w/baseplate, rotating luer; lot # 3553144 was received and visually inspected.As received, all five nanoclaves ports were separated from the manifold body due to insufficient uv adhesive coverage at the bonded connection.The probable cause is due to an error in the manual bonding process during assembly.The device history review (dhr) for lot number 3553144 was reviewed and there were no relevant non-conformances found.
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Search Alerts/Recalls
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