Model Number A2-80071-DF120 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/21/2017 |
Event Type
malfunction
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Manufacturer Narrative
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The manufacturer is still waiting for the arrival of the iv sets.
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Event Description
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The user reported a tubing seperation issue of the iv set during infusion.The tubing disconnected from the filter house.No patient harm or injury was involved in this case.
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Manufacturer Narrative
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The user reported issue was not duplicated using the unused samples from the same lot number.The failed iv set was not captured by the user, but samples from the same lot number were sent back to zyno medical for evaluation.The test result was available on 04/13/2017.
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Event Description
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This is a follow-up for the initially filed mdr (3006575795-2017-00090).
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Search Alerts/Recalls
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