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 Codes	No Audible Alarm (1019); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/03/2025
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 reported that a dialyzer blood leak occurred three minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed inside the dialyzer.The machine, a fresenius 2008t machine, did not alarm with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 100-300 ml.There was no patient injury or medical intervention required as a result of this event.The patient¿s treatment was completed successfully.
Additional Manufacturer Narrative
An engineering and risk-based evaluation of the event was performed.The primary risk control measures in the machine are minor and major blood leak alarms.The minor blood leak and major blood leak alarms trigger an audible and visual alarm, and the major blood leak alarm also triggers a stop to the blood pump and a clamp applied to the venous return line, which stops blood circuit flow and ultrafiltration.A secondary risk control is the alarms test, included in the 2008t machine operational manual as a pre-treatment machine setup test to be conducted by the user prior to patient treatment.The instructions provide multiple methods to perform the self-test, which confirms functionality of multiple alarms, relevant for this investigation, it specifically includes a verification that the blood leak alarm sensor is operating.In addition, the device history record (dhr) was reviewed and specific tests during test & calibration, final test, the alarm override function was operating correctly and the self-test check was operating correctly.The design controls, design verification, and individual machine testing conducted by both fresenius and the clinic show no evidence that the machine failed to perform as intended.Based on the engineering and risk-based evaluation of the events reported within the complaint(s), it has been concluded no device malfunction, nonconformance, or systemic quality issue was identified.The 2008t machine/system was concluded to be performing as designed with respect to blood leaks into the dialysate not triggering the blood leak alarms, major or minor.
Event or Problem Description
A user facility reported that a dialyzer blood leak occurred three minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The blood leak was noted as being an internal blood leak.The leak was visually observed inside the dialyzer.The machine, a fresenius 2008t machine, did not alarm with a blood leak alarm.Blood leak test strips were used and tested positive for the presence of blood.There was no defect or damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was approximately 100-300 ml.There was no patient injury or medical intervention required as a result of this event.The patient¿s treatment was completed successfully.

• 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: 23246533
• Report Number: 0008030665-2025-02397
• Device Sequence Number: 21410809
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2026

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: 10/06/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 10/08/2025
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2016
• 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 DIALYZER; FRESENIUS DIALYZER
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 54 KG