MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HD SYS. CDX W/BIBAG BLUE STAR; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	191126
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: 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 (bmt) reported a hemodialysis (hd) machine had a positive blood leak incident.The bmt stated the floor staff claimed the machine never alarmed for blood leak.The bmt also stated blood was observed in the flow indicator, but not downstream from the dialyzer.The bmt was not certain of dialysate flow rates at the time or if the machine was in sequential or not.Upon follow-up, the bmt stated a patient was dialyzing on the machine and the floor staff expressed blood was observed in the blue hanson line during a patient¿s hemodialysis (hd) treatment.The bmt indicated the floor staff claimed the machine did not alarm appropriately with a blood leak alert.The bmt stated blood was reportedly observed in the flow indicator but was not observed downstream of the dialyzer.The bmt was not provided with any information regarding whether a dialyzer blood leak occurred and was instructed to check operation of the blood leak detector.The bmt was unable to provide any patient demographics or treatment prescription settings including dialysate flow rates at the time of treatment.The bmt stated as far as he was aware, there was no impact to the patient and the patient.It was unknown if the patient was able to complete treatment on the day of the reported event.The bmt stated the machine was pulled from service for the bmt to evaluate.The bmt stated the blood leak detector was tested and passed testing.The machine was bleached, re-calibrated and verified and has been returned to service.

• Brand Name: 2008T HD SYS. 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 ; +1(617)417-5172
• MDR Report Key: 25015853
• Report Number: 0008030665-2026-00810
• Device Sequence Number: 15849985
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K243237
• 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): 07/29/2026

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: Other
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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 DIALYZER.
• Patient Sex: Unknown