MAUDE Adverse Event Report: Vantive US Healthcare LLC Revaclear; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	114745
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction

• Brand Name: Revaclear
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): Vantive US Healthcare LLC; deerfield IL
• Manufacturer (Section G): VANTIVE HEALTHCARE - HECHINGEN BADEN DIALYZER; holger-crafoord-strasse 26; hechingen, baden-wurttemberg NA 72379 ; GM 72379
• Manufacturer Contact: 510 lake cook rd; deerfield, il, IL 60015 ; +1(815)307-2966
• MDR Report Key: 50808965
• Report Number: 9611369-2026-00122
• Device Sequence Number: 8900167
• Product Code: KDI
• UDI-Device Identifier: 07332414114916
• UDI-Public: 07332414114916
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 114745
• Device Lot Number: 6-9214-H-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Male
• Patient Weight: 129 LB