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

Catalog Number	03-2722-9C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/06/2026
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 registered nurse (rn) reported that a fresenius combiset bloodline had a loose connection between the clic blood chamber window and the red arterial port connector piece resulting in blood loss during a patient¿s hemodialysis (hd) treatment.The issue occurred immediately after the initiation of treatment.The machine, a fresenius 2008t machine, did not alarm but was not expected to.A fresenius dialyzer was also in use.There were no loose connections or issues during priming.There were no changes to pressure or blood flow rate during treatment.There was no visible damage to the bloodline.The patient¿s estimated blood loss (ebl) was approximately 5ml.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 as a result of this event.The complaint device is not available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility¿s registered nurse (rn) reported that a fresenius combiset bloodline had a loose connection between the clic blood chamber window and the red arterial port connector piece resulting in blood loss during a patient¿s hemodialysis (hd) treatment.The issue occurred immediately after the initiation of treatment.The machine, a fresenius 2008t machine, did not alarm but was not expected to.A fresenius dialyzer was also in use.There were no loose connections or issues during priming.There were no changes to pressure or blood flow rate during treatment.There was no visible damage to the bloodline.The patient¿s estimated blood loss (ebl) was approximately 5ml.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 as a result of this event.The complaint device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• Brand Name: COMBISET SMARTECH 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: 24650409
• Report Number: 0008030665-2026-00541
• Device Sequence Number: 10208055
• Product Code: FJK
• UDI-Device Identifier: 00840861102266
• UDI-Public: 00840861102266
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201207
• 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): 04/10/2026

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: 03-2722-9C
• Device Lot Number: 25NR01043
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2025
• 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 DIALYZER; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 53 KG