MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  Death  

Manufacturer Narrative

This is one of two device reports related to this event.Additional information has been requested and will be submitted upon receipt accordingly.

Event Description

The plaintiff's attorney alleged that he patient experienced a sudden cardiac event and expired two days later.It was alleged that the event occurred due to exposure of the product administered while receiving dialysis.

• 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: 5060292
• MDR Text Key: 25179368
• Report Number: 1225714-2015-07051
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2015
• 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: 08/25/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening