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	12/18/2025
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
It was reported to fresenius that a blood leak occurred during the patient¿s hemodialysis (hd) treatment with the combiset bloodlines.A hole occurred in the blood pump tubing segment that allowed air to enter the circuit and resulted in a blood leak.Additional information was obtained during follow-up.The reported issue occurred approximately two hours after treatment initiation.A blood leak was visually observed by the clinic staff.Treatment was paused.The patient¿s blood was returned.The patient¿s estimated blood loss (ebl) was not quantified.No serious injury or required medical intervention resulted from the reported issue.Treatment was resetup on the same machine and completed with new supplies.The sample was discarded and is not available to be returned to the manufacturer for physical evaluation.The machine was pulled from service following treatment.An evaluation was performed and no issues were identified.The machine was returned to service.
Event or Problem Description
It was reported to fresenius that a blood leak occurred during the patient¿s hemodialysis (hd) treatment with the combiset bloodlines.A hole occurred in the blood pump tubing segment that allowed air to enter the circuit and resulted in a blood leak.Additional information was obtained during follow-up.The reported issue occurred approximately two hours after treatment initiation.A blood leak was visually observed by the clinic staff.Treatment was paused.The patient¿s blood was returned.The patient¿s estimated blood loss (ebl) was not quantified.No serious injury or required medical intervention resulted from the reported issue.Treatment was resetup on the same machine and completed with new supplies.The sample was discarded and is not available to be returned to the manufacturer for physical evaluation.The machine was pulled from service following treatment.An evaluation was performed and no issues were identified.The machine was returned to service.
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 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: 23854415
• Report Number: 0008030665-2025-03048
• Device Sequence Number: 5081332
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 25LR01028
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 12/19/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2025
• 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 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 75 KG