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

Catalog Number	190766
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical support that a 2008t machine¿s blood pump rotor cut through 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 and a patient care technician (pct) familiar with the event.The machine began alarming with an air detector message approximately two hours into the hd treatment.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.It was alleged that a tubing guide on the blood pump rotor came loose and damaged the tubing.When the bloodline was removed from the blood pump rotor, a visible slit 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 pct noticed the leak, the dialysis treatment was stopped.The patient¿s blood was not returned.Estimated blood loss (ebl) due to the event was 250 ml.The machine was removed from service for evaluation.The patient was able to complete their treatment after being re-setup with new supplies on a different machine.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 biomed fixed the machine by replacing the blood pump rotor.The machine was then returned to service.No sample was available to be returned for evaluation; the damaged blood pump rotor was discarded.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However, the complaint investigation found objective evidence indicating a product problem, and thus the complaint was confirmed.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.Based on the available information, the reported event has been confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius technical support that a 2008t machine¿s blood pump rotor cut through 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 and a patient care technician (pct) familiar with the event.The machine began alarming with an air detector message approximately two hours into the hd treatment.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.It was alleged that a tubing guide on the blood pump rotor came loose and damaged the tubing.When the bloodline was removed from the blood pump rotor, a visible slit 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 pct noticed the leak, the dialysis treatment was stopped.The patient¿s blood was not returned.Estimated blood loss (ebl) due to the event was 250 ml.The machine was removed from service for evaluation.The patient was able to complete their treatment after being re-setup with new supplies on a different machine.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 biomed fixed the machine by replacing the blood pump rotor.The machine was then returned to service.No sample was available to be returned for evaluation; the damaged blood pump rotor was 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 SYSTEM W/BIBAG
• 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: 23717361
• Report Number: 0008030665-2025-02925
• Device Sequence Number: 18749608
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• 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): 03/10/2026

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: 190766
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2018
• 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.; FRESENIUS BLOODLINES.; FRESENIUS OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 74 KG