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	09/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility registered nurse (rn) reported a blood leak from the venous line.Upon follow-up, the rn stated a blood leak occurred from a small hole on the venous line tubing thirty minutes after initiation of hemodialysis (hd) treatment.The machine, a 2008t, did not alarm as the blood leak was visually detected and treatment was immediately halted.A fresenius fx coral 60 dialyzer was being used during the incident.Blood test strips were not required or used.The patient's blood was not returned and the estimated blood loss (ebl) was 300 ml.The rn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.Following the event, the patient was re-setup with new supplies on a different machine and completed treatment without further issue.The combi set was discarded and was no longer available to be returned for evaluation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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 ; +1(617)417-5172
• MDR Report Key: 50768019
• Report Number: 0008030665-2026-02462
• Device Sequence Number: 10416472
• Product Code: FJK
• UDI-Device Identifier: 00840861102402
• UDI-Public: 00840861102402
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 09/15/2026

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: 26JR01051
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2026
• 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 Coral FX 60 Dialyzer
• Patient Sex: Male
• Patient Weight: 180 LB