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

Catalog Number	191126
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical technician (bmt) reported to technical support that a 2008t machine was powering down as soon as it goes into a mode.Technical support had the bmt turn off the heater breaker.When going into rinse, the machine stayed on.Technical support advised swapping the heater rod.Upon follow up, the bmt replaced the heater cord after it was found to be burnt out to resolve the issue.The machine is back in service.It was confirmed that there was no patient involvement, harm, or adverse events associated with the reported issue.No pictures were provided.No part number or lot number of the part was provided.No parts are available for return.Upon further follow up, the bmt reported that there was no observed burning smell, smoke, spark, flame, arcing.The machine powering down occurred during setup for treatment.The bmt was not at the machine and could not report the machine hours, software version, or e-codes.The cord was the original part on the machine.The machine has not had any past problems with failing electrical leakage tests.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.There was no damage to any other components related to the reported event.
Event or Problem Description
A biomedical technician (bmt) reported to technical support that a 2008t machine was powering down as soon as it goes into a mode.Technical support had the bmt turn off the heater breaker.When going into rinse, the machine stayed on.Technical support advised swapping the heater rod.Upon follow up, the bmt replaced the heater cord after it was found to be burnt out to resolve the issue.The machine is back in service.It was confirmed that there was no patient involvement, harm, or adverse events associated with the reported issue.No pictures were provided.No part number or lot number of the part was provided.No parts are available for return.Upon further follow up, the bmt reported that there was no observed burning smell, smoke, spark, flame, arcing.The machine powering down occurred during setup for treatment.The bmt was not at the machine and could not report the machine hours, software version, or e-codes.The cord was the original part on the machine.The machine has not had any past problems with failing electrical leakage tests.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.There was no damage to any other components related to the reported event.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a biomedical technician (bmt).To resolve the reported issue, the bmt replaced the heater cord.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 bmt identified a burnt-out heater cord.Therefore, the complaint event was confirmed.

• Brand Name: 2008T HD SYS. 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: 50434656
• Report Number: 0008030665-2026-02283
• Device Sequence Number: 16051743
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2026

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: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 08/25/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2025
• 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