MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Death (1802)

Event Date 11/10/2008

Event Type  Death  

Event Description

The plaintiff's attorney alleged that the pt experienced a sudden cardiac event and expired six days later.These claims were allegedly caused by the exposure to the product administered during dialysis treatment.

Manufacturer Narrative

This is one of two device reports associated with this event.

• Brand Name: NATURALYTE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; waltham MA
• Manufacturer Contact: kelly vazquez ; 920 winter street; waltham, MA 02451 ; 7816999071
• MDR Report Key: 4758259
• MDR Text Key: 17210370
• Report Number: 1225714-2015-02667
• 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: Other,Consumer
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2015
• 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: 04/16/2015
• 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