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

Catalog Number	191124
Medical Device Problem Code	Thermal Decomposition of Device (1071)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine failed sending data to the actuator board during power up.During repair, the bmt noted that there were burn marks and charring on the 24 volt cable, motherboard and the functional board.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 parts were the original fresenius parts 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 to any other components.The machine hours were unknown.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt is waiting for parts to arrive to repair the machine.No samples are available to be returned to the manufacturer for physical evaluation.
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 and an on-site evaluation was not 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-conformance's, 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 manufacturing investigation was able to confirm the reported event based on the follow up information provided by the biomedical technician.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine failed sending data to the actuator board during power up.During repair, the bmt noted that there were burn marks and charring on the 24 volt cable, motherboard and the functional board.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 parts were the original fresenius parts 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 to any other components.The machine hours were unknown.The machine is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt is waiting for parts to arrive to repair the machine.No samples are available to be returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HD SYS. CDX 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: 21664295
• Report Number: 0008030665-2025-00671
• Device Sequence Number: 12691176
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/13/2025

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: 191124
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• 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
• Patient Race: Black Or African American