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	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine had low conductivity.During repair, the bmt found that the bicarbonate pump ribbon cable and distribution board cover were scorched due to the bicarbonate pump overheating.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.It is unknown if the machine has been returned to service.The complaint device is not available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.
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.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine had low conductivity.During repair, the bmt found that the bicarbonate pump ribbon cable and distribution board cover were scorched due to the bicarbonate pump overheating.A patient was not connected to the machine at the time of the incident and there was no harm to any patients or individuals because of this malfunction.It is unknown if the machine has been returned to service.The complaint device is not available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.

• 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 ; 6174175172
• MDR Report Key: 24376918
• Report Number: 0008030665-2026-00346
• Device Sequence Number: 12181665
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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,Followup
• Report Date (Section B): 05/22/2026

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?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2024
• 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