Model Number N/A |
Device Problems
Fluid/Blood Leak (1250); Smoking (1585)
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Patient Problem
No Patient Involvement (2645)
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Event Date 03/15/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that a leak and smoke were observed from the back of a phoenix dialysis machine.This was noticed when powering up the machine.There was no patient involvement.The machine remained in clinical use after the event with no further issues reported.Additional information was requested, but is not available at this time.
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Manufacturer Narrative
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The device was not received for evaluation; therefore, a device analysis could not be performed.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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