MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Device Problem Insufficient Information (3190)

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

Event Date 02/11/2015

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 cardiac arrest and expired, which is alleged to have been caused by the product administered to the patient for dialysis treatment.

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 1225714-2016-00077 and 1225714-2016-00078.

• Brand Name: GRANUFLO
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 920 winter street; waltham MA 02451
• Manufacturer (Section G): CORPORATE; 920 winter street; waltham MA 02451
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5495724
• MDR Text Key: 40178426
• Report Number: 1225714-2016-00077
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/23/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening