MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION THERANOVA 500; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115579

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

Patient Problems Dyspnea (1816); Bronchospasm (2598)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a patient experienced hypersensitivity reaction during treatment with a theranova 500 dialyzer, approximately 10 minutes after starting treatment.The patient experienced difficulty breathing, 70% desaturation, "hypota 9/6" and pulmonary bronchospasm.The patient was disconnected without blood restitution.The patient was treated with oxygen and solumedrol + bricanyl¿.Treatment was continued with a non-baxter dialyzer.No additional information is available.

Manufacturer Narrative

H10: 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 500
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10819101
• MDR Text Key: 215983585
• Report Number: 9611369-2020-00157
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 07332414119843
• UDI-Public: (01)07332414119843
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 115579
• Device Lot Number: 9-6808-H-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BATH: BBRAUN SW381; HEPARINE CHOAY; LINES / BIBAG FRESENIUS; MEDIKIT
• Patient Outcome(s): Required Intervention