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

Device Problem Insufficient Information (3190)

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

Event Date 10/13/2014

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 the patient experienced acute cardiac arrest and expired, which is alleged to have been due to the use of the product.

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 the patient experienced acute cardiac arrest and expired, which is alleged to have been due to the use of the product.

• Brand Name: NATURALYTE ACID CONCENTRATE
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NA; 920 winter street; waltham MA 02451
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 6028397
• MDR Text Key: 57396399
• Report Number: 1225714-2016-00139
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2016
• 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
• Device Age: MO
• Date Manufacturer Received: 11/23/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening