MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	191130
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported that the machine would not complete heat disinfection.The heater rod was replaced as the heater rod was discolored.Upon follow up, it was reported that there was thermal damage on the heater rod.The heater rod was replaced and the machine was able to go through heat disinfection.There was no patient involvement as the reported issue was noted during heat disinfection.The heater rod was discarded.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility reported that the machine would not complete heat disinfection.The heater rod was replaced as the heater rod was discolored.Upon follow up, it was reported that there was thermal damage on the heater rod.The heater rod was replaced and the machine was able to go through heat disinfection.There was no patient involvement as the reported issue was noted during heat disinfection.The heater rod was discarded.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the heater rod.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was able to confirm the reported failure mode.During the machine inspection, the fresenius fst identified thermal damage on the heater rod.Therefore, the complaint event was confirmed.

• Brand Name: 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; +1(617)417-5172
• MDR Report Key: 25579898
• Report Number: 0008030665-2026-01326
• Device Sequence Number: 9020168
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K243237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

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: 191130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 06/22/2026
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2022
• 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