MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 01/22/2012

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 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: NATURALYTE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; waltham MA
• Manufacturer Contact: corie vazquez ; 920 winter street; waltham, MA 02451 ; 7816999071
• MDR Report Key: 5077662
• MDR Text Key: 25890019
• Report Number: 1225714-2015-07359
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K981043
• 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: 09/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• 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: 09/02/2015
• 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