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 02/18/2013

Event Type  Death  

Manufacturer Narrative

(b)(4).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 cardiac arrest and expired after receiving dialysis treatment.It was further alleged that the event was caused by the product.

Manufacturer Narrative

The product was not returned and lot or serial numbers are not available.The product is manufactured to meet the association for the advancement of medical instrumentation requirements using validated processes, and released based on a determination that the finished product meets those requirements.Product is not released if it does not meet requirements or is nonconforming.Complaint cannot be confirmed based on current information.A supplemental report will be filed if additional information becomes available.This is one of two device reports for this event; the associated mfr report numbers are: 1225714-2016-00067 and 1225714-2016-00068.

• 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: 5495876
• MDR Text Key: 40199392
• Report Number: 1225714-2016-00068
• 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: 03/25/2016

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: 03/02/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• 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
• Patient Age: 64 YR