MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HEMODIALYSIS SYSTEM W/BIBAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190766
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A biomedical technician (bmt) reported to technical support that a 2008t machine displayed intermittently a 'blood leak not cal' message, after the machine had been off.The bmt had swapped the blood leak detector, actuator-test board and cable, sensor board and cable, function board and eeprom, distribution board and mother board.The blood leak had been calibrated.The bmt was advised to swap hydraulics to see if its a card cage or hydraulics issue.Upon follow-up, the bmt stated that the blood leak module was bad and they were using an old one thinking it was a new one.When the bmt replaced it for a new one, they noted thermal damage on the cable.No parts were returned for evaluation.No photos were available.The part and lot numbers of the replaced component could not be provided at the time of the call.It was confirmed that there was no patient involvement, harm, or adverse events associated with the reported issue.
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 displayed intermittently a 'blood leak not cal' message, after the machine had been off.The bmt had swapped the blood leak detector, actuator-test board and cable, sensor board and cable, function board and eeprom, distribution board and mother board.The blood leak had been calibrated.The bmt was advised to swap hydraulics to see if its a card cage or hydraulics issue.Upon follow-up, the bmt stated that the blood leak module was bad and they were using an old one thinking it was a new one.When the bmt replaced it for a new one, they noted thermal damage on the cable.No parts were returned for evaluation.No photos were available.The part and lot numbers of the replaced component could not be provided at the time of the call.It was confirmed that there was no patient involvement, harm, or adverse events associated with the reported issue.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.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.Complaint investigation found objective evidence indicating a product problem, thus the complaint is confirmed.

• Brand Name: 2008T HEMODIALYSIS SYSTEM W/BIBAG
• 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 ; 6174175172
• MDR Report Key: 23423831
• Report Number: 0008030665-2025-02598
• Device Sequence Number: 8198115
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• 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): 06/04/2026

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: 190766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• 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