MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA GRANUFLO

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 06/28/2005

Event Type  Death  

Event Description

The plaintiff's attorney alleged that the patient experienced a heart attack and subsequently expired, which is alleged to have been caused by the patient's exposure to the product administered during dialysis treatment.

Manufacturer Narrative

This is one of two device reports related to this event.A follow up report will be submitted upon receipt of any additional information.

• 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: 4948931
• MDR Text Key: 6635380
• Report Number: 1225714-2015-05604
• 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
• Type of Report: Initial
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2015
• 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
• Date Manufacturer Received: 07/17/2015
• 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