MAUDE Adverse Event Report: Schweinfurt 5008X CAREsystem + CLiC + CDX; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	M204441
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury

• Brand Name: 5008X CAREsystem + CLiC + CDX
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): Schweinfurt; hafenstraße 9; schweinfurt 97424 ; GM 97424
• MDR Report Key: 50812400
• Report Number: 0001225714-2026-00011
• Device Sequence Number: 18306173
• Product Code: KDI
• UDI-Device Identifier: 00840861102433
• UDI-Public: 00840861102433
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K243505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/17/2026
• Report Date (Section F): 09/17/2026

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: Other
• Device Catalogue Number: M204441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/26/2026
• Device Age: MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/17/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2026
• Date Device Manufactured: 03/25/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/17/2026