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

Catalog Number	190858
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	12/24/2024
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
The biomedical technician (biomed) for a user facility reported to fresenius technical services that thermal decomposition was discovered within the 2008t machine.The biomed stated the 2008t machine was initially removed from service for leaking.The biomed could not confirm whether the machine leaked during patient treatment but confirmed that there was no patient adverse event, serious injury, or required medical intervention reported with this issue.An evaluation was performed and a broken ultrafiltration (uf) check valve was determined to be the cause of the reported leak.The biomed also noted thermal decomposition on the flow motor.The biomed explained that the uf check valve leaked onto the flow motor and caused it to overheat.The uf check valve and the flow motor were replaced.The biomed ran functional testing and noted an ¿electrical burn¿ smell.The machine was powered off.Upon further inspection, the biomed noted the top of valve 33 had melted.There was no observed smoke, spark, flame, or arcing.No smoke detector was triggered and use of a fire extinguisher was not required.Valve 33 was replaced to resolve this issue.The machine was returned to service following repair.There was no harm to any individuals as a result of the reported issue.The biomed confirmed the sample is available to be returned to the manufacturer for physical evaluation via return goods authorization (rga).
Event or Problem Description
The biomedical technician (biomed) for a user facility reported to fresenius technical services that thermal decomposition was discovered within the 2008t machine.The biomed stated the 2008t machine was initially removed from service for leaking.The biomed could not confirm whether the machine leaked during patient treatment but confirmed that there was no patient adverse event, serious injury, or required medical intervention reported with this issue.An evaluation was performed and a broken ultrafiltration (uf) check valve was determined to be the cause of the reported leak.The biomed also noted thermal decomposition on the flow motor.The biomed explained that the uf check valve leaked onto the flow motor and caused it to overheat.The uf check valve and the flow motor were replaced.The biomed ran functional testing and noted an ¿electrical burn¿ smell.The machine was powered off.Upon further inspection, the biomed noted the top of valve 33 had melted.There was no observed smoke, spark, flame, or arcing.No smoke detector was triggered and use of a fire extinguisher was not required.Valve 33 was replaced to resolve this issue.The machine was returned to service following repair.There was no harm to any individuals as a result of the reported issue.The biomed confirmed the sample is available to be returned to the manufacturer for physical evaluation via return goods authorization (rga).
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the balancing chamber valve was returned to the manufacturer for physical evaluation.Thermal decomposition was noted in the body of the valve and there was corrosion identified on the terminals.The flow motor and check valve were not returned for analysis.The reported issue was confirmed.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.

• Brand Name: 2008T HEMODIALYSIS SYSTEM WITHOUT CDX
• 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: 21028539
• Report Number: 0008030665-2024-01366
• Device Sequence Number: 4008300
• Product Code: KDI
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2026

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: 190858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2024
• Supplement Date Received by Manufacturer: 07/17/2026
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 07/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2015
• 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