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 Dyspnea (1816); Rash (2033)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

Reporter phone number: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced severe rashes and shortness of breath 2 hours after starting treatment with a theranova 400.The patient was treated with "2 antihistamines" (not further specified).It was reported the patient was switched to a polyflux 140h dialyzer and has recovered from the event.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: 10432220
• MDR Text Key: 203846176
• Report Number: 9611369-2020-00108
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• 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: 09/17/2020

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 115578
• Device Lot Number: 0-6601-H-01
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 09/01/2020
• Supplement Dates FDA Received: 09/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR