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); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to technical service that a spark was noted coming from the blood pump module of a fresenius 2008t machine.The biomed stated the blood pump module was brand new (out of the box).Additional details were provided upon follow-up with the biomed.The biomed was replacing the blood pump module because of an a.22 error code that the machine was displaying.The spark occurred when the machine was turned on and the module was pushed into place.The spark came from the metal on the board mounts.The biomed said the board mounts on the part were weak, and the board was moving around a lot.After the spark occurred, the biomed noticed a burn mark on the metal frame behind the blood pump module.A photo of this was provided for review.The functional board failed as a result of the blood pump issue.The biomed was able to fix the machine by replacing the blood pump module and functional board.The biomed noted that the replacement blood pump module had stronger mounts (an older design).No damage was identified on any other components.There was no burning smell, and there were no signs of any smoke, sparks, or flames.The machine had 39,814 operating hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed confirmed the machine would be returned to service upon completion of testing.The damaged blood pump module was reportedly available to be sent back for manufacturer evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: h3 plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).The reported event was able to be confirmed by referencing the provided photo where a burn mark can be observed.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 reported event has been confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported to technical service that a spark was noted coming from the blood pump module of a fresenius 2008t machine.The biomed stated the blood pump module was brand new (out of the box).Additional details were provided upon follow-up with the biomed.The biomed was replacing the blood pump module because of an a.22 error code that the machine was displaying.The spark occurred when the machine was turned on and the module was pushed into place.The spark came from the metal on the board mounts.The biomed said the board mounts on the part were weak, and the board was moving around a lot.After the spark occurred, the biomed noticed a burn mark on the metal frame behind the blood pump module.A photo of this was provided for review.The functional board failed as a result of the blood pump issue.The biomed was able to fix the machine by replacing the blood pump module and functional board.The biomed noted that the replacement blood pump module had stronger mounts (an older design).No damage was identified on any other components.There was no burning smell, and there were no signs of any smoke, sparks, or flames.The machine had 39,814 operating hours on it.The machine was plugged into a hospital grade ground-fault circuit interrupter (gfci) outlet and had no previous history of failing the electrical leakage test.The biomed confirmed the machine would be returned to service upon completion of testing.The damaged blood pump module was reportedly available to be sent back for manufacturer 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: 23060009
• Report Number: 0008030665-2025-02209
• Device Sequence Number: 9680307
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• 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