Device Problem
Insufficient Information (3190)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 12/29/2013 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).This is one of two device reports that are associated with this event.Additional information has been requested and will be submitted upon receipt accordingly.
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Event Description
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The plaintiff's attorney alleged that the patient experienced a sudden cardiac arrest and expired approximately three days later, which is alleged to have been caused by the patient's exposure to the product administered during dialysis treatments.
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Manufacturer Narrative
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This is one of two device reports that are associated with this event; associated manufacturer report numbers: 1225714-2016-00103 and 1225714-2016-00104.Additional information has been requested and will be submitted upon receipt accordingly.
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Search Alerts/Recalls
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