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

Catalog Number	03-2722-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/19/2026
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 corporate inventory manager reported to fresenius that a combi set blood leak occurred at a hemodialysis (hd) user clinic.Additional information was obtained through follow-up with the facility administrator (fa) and a patient care technician (pct) from the clinic.It was reported that the saline line separated at the end of a patient¿s hd treatment, as their blood was being reinfused.The saline line separated from the ¿t¿ connector.The pct was at the station when this occurred, and they were able to immediately clamp off the lines once they noticed the issue.There were no alarms from the machine.There did not appear to be any loose connections leading up to the event, and no leaks were noticed during the priming phase.Additionally, there were no changes or disruptions in pressure that could have contributed to the failure.It was reported that the patient¿s treatment was completed.Only a drop of blood leaked out.Per the pct, the estimated blood loss (ebl) was maybe 1ml.It was confirmed that there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The combi set was not available to be returned for manufacturer evaluation as it was reportedly discarded.However, a photo depicting the separation was provided for review.

• Brand Name: CUSTOM COMBI SET
• 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: 24849061
• Report Number: 0008030665-2026-00673
• Device Sequence Number: 18374499
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K962081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: 03-2722-9
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 OPTIFLUX DIALYZER
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 74 KG