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	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s clinic manager (cm) reported that on (b)(6) 2026, a fresenius combiset bloodline caused a saline bag to backfill with blood one hour after the initiation of a patient¿s hemodialysis (hd) treatment.All of the clamps on the saline bag were clamped and blood pulled from the bloodlines back into the empty saline bag.The backfill was visually observed.The machine, a fresenius 2008t machine, alarmed appropriately with an air detector alarm.There were no filling programs on the machine.The cm reported that there were no quick disconnects on the drain line and that the drain line length and height were within specification.The machine was not removed from service following this incident and has not experienced a recurrence of the issue.A fresenius dialyzer was also in use.Following the incident, the patient¿s blood was rinsed back; however, the blood that backed up in to the saline bag could not be returned.The patient¿s estimated blood loss (ebl) was approximately 50ml.The patient was restarted on the same machine and treatment completed successfully with new supplies.There was no patient serious injury or medical intervention required due to this event.The complaint device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 24334135
• Report Number: 0008030665-2026-00308
• Device Sequence Number: 14655819
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2026

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
• Device Lot Number: 25LR01027
• 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: 02/04/2026
• Supplement Date Received by Manufacturer: 05/25/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2025
• 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 BLOODLINES; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 68 KG