MAUDE Adverse Event Report: FRESENIUS NATURALYTE 2.25 CA; DIALYSATE CONCENTRATE FOR HEMODIALYSIS LIQUID OR POWDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Chest Pain (1776); Pain (1994); Respiratory Distress (2045); Burning Sensation (2146); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Naturalyte was used during dialysis.I became short of breath and developed chest pain.Three weeks later, i am still short of breath, can't lay down to sleep and have pain between shoulder blades.During dialysis i was given naturalyte for the first time.Once treatment was completed i went home and was sick all night.Three days later, i required oxygen, developed a heavy chest pressure in the center of my chest and became sob.Went to er where ct scan chest xray, ekg and labs completed.Symptoms continue to persist.I still can't lay down at right to sleep and there is a burning sensation in middle of shoulder blades.Stress test at (b)(6) hospital on (b)(6) 2018.Required er visit, testing and was placed on oxygen for short period of time.Date of use: (b)(6) 2018.The problem did not stop after the person reduced the dose or stopped taking or using the product."did the problem return if the person started taking or using the product again: didn't restart." frequency: 3 x weeks dialysis."how was it taken: injection via hemodialysis." reason for use: dialysis clinic stated they used it for high k+ level.

• Brand Name: NATURALYTE 2.25 CA
• Type of Device: DIALYSATE CONCENTRATE FOR HEMODIALYSIS LIQUID OR POWDER
• Manufacturer (Section D): FRESENIUS
• MDR Report Key: 7376800
• MDR Text Key: 103803684
• Report Number: MW5076171
• Device Sequence Number: 1
• Product Code: KPO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Weight: 95