MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190713
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/26/2025
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 biomedical technician (biomed) reported to fresenius technical support that a 2008t machine¿s blood pump rotor cut the blood tubing during a patient¿s hemodialysis (hd) treatment which resulted in blood loss.Additional details were provided upon follow-up with the biomed.The machine alarmed with an air detected message and blood was observed leaking from the blood pump.The biomed was unsure how long into the treatment this occurred.There were no unusual noises coming from the blood pump.Upon inspection of the setup, it was noted that blood was leaking from the tubing within the blood pump.The biomed said the cap on one of the blood pump rotor guides came loose and damaged the tubing.When the nipro bloodline was removed from the blood pump rotor, a visible cut was observed on the blood pump tubing segment.The bloodline was inspected for damage prior to treatment initiation, and there were no apparent defects noted at that time.Once the leak was noticed, the dialysis treatment was stopped.The patient¿s blood was not returned.Estimated blood loss (ebl) due to the event was about 200 ml.The machine was removed from service for evaluation.The biomed said the loose cap completely fell off when the blood pump rotor was removed.The biomed fixed the machine by replacing the rotor.The machine was then returned to service.No sample was available to be returned for evaluation; the damaged blood pump rotor was discarded.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 patient was able to complete their treatment after being re-setup with new supplies on a different machine.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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 ; 6174175172
• MDR Report Key: 24086168
• Report Number: 0008030665-2026-00110
• Device Sequence Number: 21253681
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K150708
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 01/15/2026

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: 190713
• 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: 12/26/2025
• Initial Report FDA Received Date: 01/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2015
• 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
• Patient Sex: Unknown