MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HD SYS. CDX W/BIBAG BLUE STAR; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	191126
Medical Device Problem Codes	Fluid/Blood Leak (1250); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/16/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse reported that there was a blood leak during a hemodialysis (hd) treatment.The machine began alarming "air".Once inspected, it was noted that blood was leaking from the line on the blood pump area.After removal of combi set in blood pump, there was a puncture mark in the tubing allowing blood to leak and air to get into the section of the blood line that was in the blood pump.In a follow up, the nurse said the blood leak occurred approximately 2 hours 15 min after hemodialysis (hd) treatment was started.There was and air detected alarm on the 2008t machine.An optiflux dialyzer was being used.The leak was due to the combiset line being punctured or split.Obvious damage to the bloodline was noticed when the line was removed from the blood pump rotor.There were no loose connections noted.There was damage seen to the tubing.The rotor part number is f40014866.It was determined the blood pump rotor was faulty and it was replaced.It had not been replaced before.The rotor was an affected rotor.The patient¿s blood loss was approximately 100ml.There was no patient injury, intervention or adverse event.The patient completed treatment with new bloodlines and a different machine.The 2008t machine was returned to service.The sample is not available to return.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: 2008T HD SYS. CDX W/BIBAG BLUE STAR
• Common Device Name: Dialyzer, High Permeability With Or Without Sealed Dialysate System
• 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: 50935161
• Report Number: 0008030665-2026-02594
• Device Sequence Number: 21514111
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K243237
• 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): 09/29/2026

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: 191126
• 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: 09/16/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Fresenius Dialyzer; Fresenius bloodlines
• Patient Sex: Female
• Patient Weight: 176 LB