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 01/19/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).This is one of two device reports for this event; there are a total of two events for this patient.The associated mfr report numbers for the second event are: 1225714-2014-14518 and 1225714-2014-14519.Additional information has been requested and will be submitted upon receipt accordingly.

Event Description

The plaintiff's attorney alleged that the patient experienced a sudden cardiac event and expired on the same day, which is alleged to have been caused by the patient's exposure to the product administered during dialysis treatment.

• 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: 5484668
• MDR Text Key: 39826963
• Report Number: 1225714-2016-00060
• 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
• Report Date: 03/07/2016

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
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/07/2016
• 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