MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA NATURALYTE; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Device Problem Insufficient Information (3190)

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

Event Date 05/09/2013

Event Type  Death  

Manufacturer Narrative

(b)(4).This is one of three device reports that are associated with 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 impairments, including but not limited to, cardiac arrest and subsequently expired, which is alleged to have been caused by the product administered to the patient during dialysis treatment.Patient received dialysis treatments for approximately three years.

Manufacturer Narrative

Updated with information from the completed product evaluation.This is one of three device reports that are associated with this event; associated manufacturer report numbers: 1225714-2016-00119, 1225714-2016-00120 and 2937457-2016-00564.Additional information has been requested and will be submitted upon receipt accordingly.

• Brand Name: NATURALYTE
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 920 winter street; waltham MA 02451
• Manufacturer (Section G): CORPORATE; 920 winter street; waltham MA 02451
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5689624
• MDR Text Key: 46251388
• Report Number: 1225714-2016-00120
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/09/2016

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: 05/11/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2016
• 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