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	04/03/2026
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
It was reported that this patient on hemodialysis experienced blood loss (a full hemodialysis circuit; approximately 300 ml) requiring hemoglobin monitoring.It was reported that the twister apparatus on the fresenius access flow combiset blood lines dissected upon rotation of the device.In additional follow-up via email and a call with a hemodialysis nurse.It was discovered that with in one hour of the treatment, the patient was having an access flow test performed and when the twister apparatus on the fresenius combiset was rotated the device cracked.It was confirmed that there were no internal blood leaks and no allegations against the fresenius hemodialysis machine or dialyzer.It was stated a visible crack was observed with visible blood leak on the fresenius combiset.As a result, the patient¿s treatment was ended.The patient was not returned their blood in the hemodialysis circuit.The hemodialysis nurse reported that there was no change in the patient¿s blood pressure.The patient was reset up with new supplies and received 250ml of saline from the newly primes dialysis circuit (standard of care).The nurse confirmed that the patient did not require any medical intervention for the reported blood loss of approximately 300ml.Additionally, the nurse stated the patient¿s hemoglobin was monitored after the event and the following hemodialysis treatment.However, it was confirmed that the patient did not have any changes in hemoglobin or require medical intervention.

• 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 ; +1(617)417-5172
• MDR Report Key: 25129160
• Report Number: 0008030665-2026-00884
• Device Sequence Number: 13330153
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2026

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: 03-2794-0
• Device Lot Number: 25SR01152
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Supplement Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2025
• 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 MACHINE
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 136 LB