Model Number 102956 |
Device Problems
Insufficient Flow or Under Infusion (2182); Noise, Audible (3273)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/15/2019 |
Event Type
Injury
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Manufacturer Narrative
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Multiple attempts were made to obtain patient information however none was provided.Date of event was estimated.Multiple attempts were made to obtain event date, however none was provided.Serial number of the devices was requested but not provided.Multiple attempts were made unable to get information.No further information was provided.A supplemental report will be submitted when the manufacture's investigation is completed.
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Event Description
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It was reported a humming noise was heard from the motor.Centrimag gen 2 monitor showed decreasing flow unresponsive to clinician¿s attempt to increase flow.Flow continued to decrease resulting in patient composition.Patient clamped off ecmo and converted to back up motor.Flow resumed without further issue.
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Manufacturer Narrative
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Section d4: additional information.
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Manufacturer Narrative
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This event was determined to be a duplicate to (b)(4), (b)(4).The manufacturer's investigation conclusion was captured under mfr# 2916596-2019-03291.
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Search Alerts/Recalls
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