MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 03/14/2008

Event Type  Death  

Event Description

The plaintiff's attorney alleged that the pt experienced a sudden cardiac event and subsequently expired on the same day. It was reported that the death occurred due to administration of naturalyte and/or granuflo during dialysis treatment.

Manufacturer Narrative

This is one event (death) for the same pt involving two separate products.

• Brand Name: GRANUFLO
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; waltham MA
• Manufacturer Contact: corie vazquez ; 920 winter street; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4640877
• MDR Text Key: 5753801
• Report Number: 1225714-2015-01513
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 03/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data

Patient Treatment Data

Date Received: 03/27/2015 Patient Sequence Number: 1