MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-2522-1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/25/2026
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 clinic manager (cm) reported the combiset heparin line became unattached from blood tubing at the connection site.Upon follow-up, the cm stated a hemodialysis (hd) patient was twenty minutes into dialysis treatment on a fresenius 2008t machine when the machine prompted with an air leak detected message, and staff noticed the heparin line was on the floor in a pool of blood.The cm stated per facility protocol the heparin lines are not used, are tired in a knot and clamped off.Treatment was immediately halted.The cm stated the machine was not affected or removed from service as the leak was observed from the disconnected tubing itself.No further damage and/or defects were noted.The cm stated the machine 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 cm stated blood from the venous side was unable to be returned.The cm stated that the patient¿s estimated blood loss (ebl) was between 250-300 ml.The cm stated there was no patient injury, adverse events, or medical intervention required as a result of the reported event.Following the event, the cm stated the patient was restarted on the same machine and treatment completed successfully with a new dialyzer and tubing lines without further issue.The complaint device was discarded and was no longer available to be returned to the manufacturer for evaluation.

• Brand Name: COMBISET BLOODLINE
• Common Device Name: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• 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: 25018942
• Report Number: 0008030665-2026-00811
• Device Sequence Number: 10332914
• Product Code: FJK
• UDI-Device Identifier: 00840861102402
• UDI-Public: 00840861102402
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K213992
• 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): 06/04/2026

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: 03-2522-1
• Device Lot Number: 25SR01053
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2025
• 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 2008T MACHINE; FRESENIUS DIALYZER
• Patient Age: 39 YR
• Patient Sex: Male
• Patient Weight: 96 KG