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	04/01/2026
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 reported that a combiset bloodline had a small hole in the arterial pump housing segment that allowed air to enter the system during a patient¿s hemodialysis (hd) treatment.It was also reported that the patient experienced blood loss.The machine did not alarm.The complaint device was reported to be available to be returned to the manufacturer for evaluation.Additional information requested but to date has not been obtained.

• 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: 25068424
• Report Number: 0008030665-2026-00840
• Device Sequence Number: 21422075
• Product Code: FJK
• UDI-Device Identifier: 00840861102402
• UDI-Public: 00840861102402
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: 25SR01099
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/04/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2025
• 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
• Patient Sex: Unknown