MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Type  Death  

Manufacturer Narrative

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 that the patient experienced injuries including cardiac event and expired, which is alleged to have been caused by the patient's exposure to the product administered during dialysis treatment.

• 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: 5117636
• MDR Text Key: 27309090
• Report Number: 1225714-2015-07570
• 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: Not Applicable
• Report Date: 09/17/2015

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: Not provided
• Initial Date FDA Received: 09/29/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening