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 Codes	Thermal Decomposition of Device (1071); Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (bmt) reported a damaged power plug.The bmt stated the black wire was damaged and needed the part number for the power cord assembly.A photo was provided.Additional information was requested but was not received to date.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: b5, h6 - medical device problem code.
Event or Problem Description
A user facility biomedical technician (bmt) reported a damaged power plug.The bmt stated the black wire was damaged and needed the part number for the power cord assembly.A photo was provided.Upon follow-up, the bmt said the machine had been repaired.The bmt replaced the power supply cable that had a plug with visual damage (described as burnt/melted).The damage was identified during regular maintenance.The bmt said this was not the original power supply cable on the machine - it had previously been replaced on an unknown date.There was no burning smell noticed.Additionally, there were no signs of smoke, sparks, or flames.The bmt said that the damage was likely identified well after it occurred.No additional information was able to be provided.No sample was available for evaluation.
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).The reported event was 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.
Event or Problem Description
A user facility biomedical technician (bmt) reported a damaged power plug.The bmt stated the black wire was damaged and needed the part number for the power cord assembly.A photo was provided.Upon follow-up, the bmt said the machine had been repaired.The bmt replaced the power supply cable that had a plug with visual damage (described as burnt/melted).The damage was identified during regular maintenance.The bmt said this was not the original power supply cable on the machine - it had previously been replaced on an unknown date.There was no burning smell noticed.Additionally, there were no signs of smoke, sparks, or flames.The bmt said that the damage was likely identified well after it occurred.No additional information was able to be provided.No sample was available for evaluation.

• 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: 24994543
• Report Number: 0008030665-2026-00797
• Device Sequence Number: 9756721
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K231125
• 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): 07/08/2026

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: 04/21/2026
• Supplement Date Received by Manufacturer: 05/14/2026; 07/08/2026
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/15/2026; 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• 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