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

Catalog Number	191130
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/24/2025
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 clinic manager reported that there was a dialyzer blood leak during a hemodialysis (hd) treatment.During treatment it was noticed that the dialyzer fibers were only streaked with blood, not filled completely with blood.In a follow up, the nurse reported that the blood leak occurred approximately 30 min prior to ending the hd treatment.The nurse explained that the leak was visually seen.The blood leak was described as being an internal blood leak.A fresenius 2008t machine was being used.The machine did not alarm with a blood leak alarm.Blood leak test strips were not used.Fresenius bloodlines were used.There was no damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was >100 ml.There was no patient injury, adverse event or medical intervention required as a result of this event.The treatment was considered completed when the leak was noted.The device is available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.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.The investigation into the cause of the reported problem was not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
A clinic manager reported that there was a dialyzer blood leak during a hemodialysis (hd) treatment.During treatment it was noticed that the dialyzer fibers were only streaked with blood, not filled completely with blood.In a follow up, the nurse reported that the blood leak occurred approximately 30 min prior to ending the hd treatment.The nurse explained that the leak was visually seen.The blood leak was described as being an internal blood leak.A fresenius 2008t machine was being used.The machine did not alarm with a blood leak alarm.Blood leak test strips were not used.Fresenius bloodlines were used.There was no damage noted on the dialyzer.The patient¿s estimated blood loss (ebl) was >100 ml.There was no patient injury, adverse event or medical intervention required as a result of this event.The treatment was considered completed when the leak was noted.The device is available to be returned to the manufacturer for evaluation.

• Brand Name: 2008T HD SYS. W/O 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 ; 6174175172
• MDR Report Key: 23343039
• Report Number: 0008030665-2025-02513
• Device Sequence Number: 9544704
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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): 12/09/2025

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: 191130
• 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: 12/04/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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: DELFLEX PD FLUID.; DELFLEX PD FLUID.; FRESENIUS OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 184 KG