MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THERANOVA 400; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115578

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Malaise (2359); Shaking/Tremors (2515)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that five minutes after starting treatment with a theranova 400 dialyzer, the patient experienced cephalic instability, blurred vision, general malaise and tremors.Treatment was discontinued, and the patient was treated with esteroids (40mg), intravenous (iv) polaramine (5 mg) and iv prednisolone (40mg).It was reported an hour after event onset, the patient was recovered from the events.It was reported treatment was restarted with a non-baxter dialyzer.No additional information is available.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THERANOVA 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9371247
• MDR Text Key: 179546201
• Report Number: 9611369-2019-00177
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

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
• Device Catalogue Number: 115578
• Device Lot Number: 9-6611-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 01/21/2020
• Supplement Dates FDA Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 64