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	06/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Correction: a1, b7.
Event or Problem Description
A biomedical technician (bmt) reported to technical support that a 2008t machine experienced fails multiple self-tests including tmp high soft, act temp high, act temp low, temp high soft, and conductivity high.The bmt stated the temperature was 37.1°c and did not change during the self-test.Customer replaced the actuator-test board.Customer placed the device in self-test twice during the call.The bmt stated the device was now functioning normally and passes the self-test.Upon follow-up, the bmt stated that it was a short electrical issue with the bicarb pump.The bmt was not able to provide more information.No photos were available and no parts were returned for evaluation.The bmt confirmed there was no patient involvement, harm, or adverse events associated with the reported issue.The machine is back in service.
Event or Problem Description
A biomedical technician (bmt) reported to technical support that a 2008t machine experienced fails multiple self-tests including tmp high soft, act temp high, act temp low, temp high soft, and conductivity high.The bmt stated the temperature was 37.1°c and did not change during the self-test.Customer replaced the actuator-test board.Customer placed the device in self-test twice during the call.The bmt stated the device was now functioning normally and passes the self-test.Upon follow-up, the bmt stated that it was a short electrical issue with the bicarb pump.The bmt was not able to provide more information.No photos were available and no parts were returned for evaluation.The bmt confirmed there was no patient involvement, harm, or adverse events associated with the reported issue.The machine is back in service.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A biomedical technician (bmt) reported to technical support that a 2008t machine experienced fails multiple self-tests including tmp high soft, act temp high, act temp low, temp high soft, and conductivity high.The bmt stated the temperature was 37.1°c and did not change during the self-test.Customer replaced the actuator-test board.Customer placed the device in self-test twice during the call.The bmt stated the device was now functioning normally and passes the self-test.Upon follow-up, the bmt stated that it was a short electrical issue with the bicarb pump.The bmt was not able to provide more information.No photos were available and no parts were returned for evaluation.The bmt confirmed there was no patient involvement, harm, or adverse events associated with the reported issue.The machine is back in service.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.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 be 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: 25643990
• Report Number: 0008030665-2026-01483
• Device Sequence Number: 21170460
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup
• Report Date (Section B): 07/29/2026

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: Other
• Device Catalogue Number: 191126
• 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: 06/16/2026
• Supplement Date Received by Manufacturer: 06/16/2026; 07/29/2026
• Initial Report FDA Received Date: 06/26/2026
• Supplement Report FDA Received Date: 06/29/2026; 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2018
• 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