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	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 5008x hemodialysis (hd) machine would not toggle to cdx/ chairside.A fme field service technician (fst) was called onsite and replaced the cdx board to resolve the issue.During that repair, the fst noted that there was a burn mark on the user interface board.The fst ordered a new user interface board for the customer.Upon follow up, the bmt said that a patient was not connected and there was no harm to any patients or individuals because of this malfunction.The user interface board was the original fresenius part on the machine.The bmt reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The bmt reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine has 189 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.He is still waiting for the part to arrive.The machine remains out of service at this time.The complaint device is available to be returned to the manufacturer for evaluation under rga (b)(4).Equipment code: 245 machine hours: 189 software version: 4.82.4 machine files: requested.
Additional Manufacturer Narrative
Additional information: b5, h6 device component code.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 5008x hemodialysis (hd) machine would not toggle to cdx/ chairside.A fme field service technician (fst) was called onsite and replaced the cdx board to resolve the issue.During that repair, the fst noted that there was a burn mark on the user interface board.The fst ordered a new user interface board for the customer.Upon follow up, the bmt said that a patient was not connected and there was no harm to any patients or individuals because of this malfunction.The user interface board was the original fresenius part on the machine.The bmt reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The bmt reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine has 189 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt received and replaced the user interface board and that did not resolve the issue.After additional troubleshooting with an fst additional parts (unknown) were ordered.The machine remains out of service as they are waiting for the new parts to arrive.The defective user interface board is being returned under rga (b)(4).One photo has been provided.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

• 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
• Manufacturer (Section G): Schweinfurt; hafenstraße 9; schweinfurt 97424 ; GM 97424
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 50917600
• Report Number: 0001225714-2026-00013
• Device Sequence Number: 17580824
• Product Code: KDI
• UDI-Device Identifier: 00840861102433
• UDI-Public: 00840861102433
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: M204441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown