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	09/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical support that blood pump rotor from a 2008t hemodialysis (hd) machine damaged the blood pump tubing segment of a bloodline during a patient¿s hd treatment.Additional details were obtained upon follow-up with the biomed and a patient care technician (pct) familiar with the event.With approximately thirty minutes remaining in the treatment, the 2008t machine began alarming with an air detector message.The pct reset the alarm, and shortly afterwards it went off again.The pct then heard a grinding noise coming from the blood pump, and they noticed blood leaking from the tubing within the blood pump.It was determined that the blood pump rotor damaged the tubing which caused the leak.When the bloodline was removed from the blood pump rotor, a visible puncture mark was noted 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 pct noticed the leak, the dialysis treatment was stopped.Blood was returned from both the arterial and venous sides of the circuit.The arterial side had to be returned by gravity.Estimated blood loss (ebl) due to the leak was 50 ml.The patient declined further treatment.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 machine was removed from service for evaluation.The biomed inspected the machine and found that the covers on two of the rotor pins were loose.When the biomed touched the covers, they fell off.The biomed fixed the machine by replacing the blood pump rotor.The machine was then returned to service.The damaged blood pump rotor was not available to be returned for evaluation as it was reportedly discarded.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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: 23161886
• Report Number: 0008030665-2025-02302
• Device Sequence Number: 9639747
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/05/2026

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: 09/19/2025
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2017
• 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 BLOODLINES
• Patient Sex: Male
• Patient Weight: 60 KG