Device Problem
Insufficient Information (3190)
|
Patient Problems
Cardiopulmonary Arrest (1765); Death (1802)
|
Event Date 12/26/2012 |
Event Type
Death
|
Manufacturer Narrative
|
(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.
|
|
Event Description
|
The plaintiff's attorney alleged that the patient experienced a sudden cardiopulmonary arrest and expired, which is alleged to have been caused by the patient's exposure to the product administered during dialysis treatments.
|
|
Manufacturer Narrative
|
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 1225714-2016-00101 and 1225714-2016-00102.
|
|
Search Alerts/Recalls
|