MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number	03-2794-0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility facility administrator (fa) reported on (b)(6) 2026 a hemodialysis (hd) patient was forty-five minutes into dialysis treatment on a fresenius 2008t (s/n (b)(6)) machine when the machine prompted with an air leak detected message, and staff noticed microbubbles in the blood pump section of the dialysis tubing line on the dialysis machine.Treatment was halted and upon removal of the tubing, the staff reported blood leak from a small hole in the line of the tubing.The fa stated the machine was not affected or removed from service as the leak was observed from the tubing line itself.No further damage and/or defects were noted.The fa stated the blood pump rotor was inspected with no noted issues and indicated the machine remained in service.A fresenius 180nre dialyzer was used for treatment and the patient's blood was partially returned from the arterial side of the system.The fa stated that the patient¿s estimated blood loss (ebl) was between 150-300 ml.The fa stated there was no patient injury, adverse events, or medical intervention required as a result of the reported event.Following the event, the fa stated the patient was restarted on the same machine and treatment completed successfully with a new dialyzer and tubing lines without further issue.Following the event, the machine was pulled from service for further evaluation by the biomedical technician.The fa stated the machine was more than 10 years old and it was unknown if and when the blood pump rotor was last replaced.The fa was unable to provide the machine hours of the machine.The complaint device was discarded and was no longer available to be returned to the manufacturer for evaluation.

• Brand Name: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 24503682
• Report Number: 0008030665-2026-00437
• Device Sequence Number: 10486159
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K022536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2026

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: 03-2794-0
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 180NRE DIALYZER.; FRESENIUS 2008T MACHINE.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 90 KG