Device Problem
Insufficient Information (3190)
|
Patient Problems
Cardiac Arrest (1762); Death (1802)
|
Event Date 06/24/2009 |
Event Type
Death
|
Manufacturer Narrative
|
(b)(4).This is one of two device reports for this event.Additional information has been requested and will be submitted upon receipt accordingly.
|
|
Event Description
|
The plaintiff's attorney alleged the patient experienced a sudden cardiac event and expired approximately five days later, which is alleged to have been caused by the patient's exposure to the product administered during dialysis treatment.
|
|
Manufacturer Narrative
|
Section was updated per the additional information received.The product was not returned and lot or serial number are not available.The product is manufactured to meet the association for the advancement of medical instrumentation requirements using validated processes, and released based on a determination that the finished product meets those requirements.Product is not released if it does not meet requirements or is nonconforming.Complaint cannot be confirmed based on the current information.A supplemental report will be filed if and when additional information becomes available.This is one of two device reports for this event.Associated mfr report numbers: 1225714-2016-00040 and 1225714-2016-00041.
|
|
Search Alerts/Recalls
|