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	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a 2008t hemodialysis (hd) had a low temperature issue due to a hydraulic fluid leak during set up.A fresenius field service technician (fst) was called onsite and noted blackening and discoloration of the heater rod indicating thermal decomposition.Follow up with the bmt revealed that 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.The heater rod was the original fresenius part on the machine.The bmt reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The bmt reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine has 667 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The fst replaced the heater rod and calibrated the heat temperature control to resolve the low temperature issue.The fst could not duplicate the fluid leak.Machine functional tests were completed and passed onsite after repair.The complaint sample is not available to be returned to the manufacturer for physical evaluation.One photo has been provided.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).To resolve the reported issue, the fst replaced the heater rod and calibrated the heat temperature control.Additionally, a photograph of the sample was provided.The photo showed thermal decomposition on heater rod.The manufacturer was able to determine a causal relationship between the objective evidence provided by the customer and the reported event.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 fresenius fst noted blackening and discoloration of the heater rod indicating thermal decomposition therefore, the complaint event was confirmed.
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a 2008t hemodialysis (hd) had a low temperature issue due to a hydraulic fluid leak during set up.A fresenius field service technician (fst) was called onsite and noted blackening and discoloration of the heater rod indicating thermal decomposition.Follow up with the bmt revealed that 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.The heater rod was the original fresenius part on the machine.The bmt reported that there was no melting, burning smell, smoke, spark, flame, or arcing observed.The bmt reported that the machine has not had any past problems with failing the electrical leakage test and that there was no damage observed on any other components.The machine has 667 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The fst replaced the heater rod and calibrated the heat temperature control to resolve the low temperature issue.The fst could not duplicate the fluid leak.Machine functional tests were completed and passed onsite after repair.The complaint sample is not available to be returned to the manufacturer for physical evaluation.One photo 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: 23167514
• Report Number: 0008030665-2025-02303
• Device Sequence Number: 13150231
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 03/10/2026

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
• Device Lot Number: N/A
• 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: 09/19/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2022
• 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