MAUDE Adverse Event Report: VANTIVE US HEALTHCARE LLC THERANOVA; HEMODIALYZER WITH EXPANDED SOLUTE REMOVAL PROFILE

Catalog Number	955692
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Hypersensitivity/Allergic reaction (1907); Hypoxia (1918); Cough (4457); Back pain (4895)
Date of Event	09/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment with an unspecified theranova dialyzer, the patient experienced shortness of breath and chest pain.It was further reported that this was the first time the patient had used a theranova dialyzer.There was no report of a medical intervention associated with this event.According to the reporter, the ¿symptoms resolving after ending therapy¿.No additional information is available.
Additional Manufacturer Narrative
A2: age at time of event: reported as "adult".The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information: b3, b5, d2a, d2b, d4, g4, h4, h6, and h11.B5: upon follow up, it was reported that the patient experienced paroxysmal coughing, back pain, and cyanosis to lips and oral mucous membranes.The patient was transported for evaluation via ems (emergency medical services).It was reported that the patient received "medical treatment on dialysis".H11: 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
• Common Device Name: HEMODIALYZER WITH EXPANDED SOLUTE REMOVAL PROFILE
• Manufacturer (Section D): VANTIVE US HEALTHCARE LLC; round lake IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - HECHINGEN BADEN DIALYZER; holger-crafoord-strasse 26; hechingen, baden-wurttemberg 72379 ; GM 72379
• Manufacturer Contact: 25212 w. il route 120; round lake, IL 60073 ; 2242706717
• MDR Report Key: 23415685
• Report Number: 9611369-2025-00181
• Device Sequence Number: 10269081
• Product Code: QAX
• UDI-Device Identifier: 07332414125721
• UDI-Public: (01)07332414125721(10)4-6926-H-01(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN190042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 955692
• Device Lot Number: 4-6926-H-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male