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	02/28/2025
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) machine would not calibrate the deaeration pressure during calibration/ service mode.Upon follow up, the bmt stated that he replaced the deaeration board to resolve the reported issue.He also reported that there was a popping sound and smoke coming from the actuator board because it had been calibrated at high power.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 actuator board and deaeration board were the original fresenius parts on the machine.The bmt reported that there was no melting, 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 12,069 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt replaced the actuator board, which resolved the issue.The bmt reported that the machine has been returned to service without issue.The samples are not available to be returned to the manufacturer for physical evaluation.
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-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 complaint investigation found objective evidence indicating a product problem, thus the reported event is confirmed.
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a 2008t hemodialysis (hd) machine would not calibrate the deaeration pressure during calibration/ service mode.Upon follow up, the bmt stated that he replaced the deaeration board to resolve the reported issue.He also reported that there was a popping sound and smoke coming from the actuator board because it had been calibrated at high power.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 actuator board and deaeration board were the original fresenius parts on the machine.The bmt reported that there was no melting, 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 12,069 hours and is plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet.The bmt replaced the actuator board, which resolved the issue.The bmt reported that the machine has been returned to service without issue.The samples are not 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: 21525958
• Report Number: 0008030665-2025-00523
• Device Sequence Number: 9712469
• Product Code: KDI
• UDI-Device Identifier: 00840861102082
• UDI-Public: 00840861102082
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: BB
• 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): 05/12/2025

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: 02/28/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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