Device Problem
Insufficient Information (3190)
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Patient Problems
Cardiac Arrest (1762); Death (1802)
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Event Date 02/11/2015 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).A supplemental report will be submitted upon completion of the plant's investigation.Additional information has been requested and will be submitted upon receipt accordingly.This is one of two device reports that are associated with this event.
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Event Description
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The plaintiff's attorney alleged that the patient experienced cardiac arrest and expired, which is alleged to have been caused by the product administered to the patient for dialysis treatment.
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Manufacturer Narrative
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Additional information was received and the following sections were updated accordingly: further attempts to obtain complete complaint details and upon receipt will be submitted accordingly.This is one of two device reports associated with this event.Related manufacturer report numbers are 1225714-2016-00077 and 1225714-2016-00078.
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Search Alerts/Recalls
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