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	Inadequate Ultra Filtration (1656)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (bmt) reported a hemodialysis (hd) patient was not getting enough fluid removed according to staff.The bmt stated the device had negative flow on and negative stabilize self-test failures.The bmt stated there was also a bibag pht failed alarm.There was patient involvement with no injury.The bmt was advised to perform the induced air leak tests and induced positive pressure tests to check the hydraulic system for leaks.The bmt was advised to recalibrate the ultrafiltration (uf) pump and to perform the bibag pressure calibration, the regulator pressure calibration, and perform a full rinse.The bmt was advised to replace the dialysate connector o-rings, loading pressure regulator, flow pressure regulator, deaeration motor, flow motor.The bmt was advised to replace possibly the uf pump, actuator-test board, valve 24, valve 26, valve 43, dialysate pressure transducer #9, or chamber full switch issues.Upon follow-up, the bmt stated the patient was able to complete treatment on the day of the reported event but did not have enough fluid removed during treatment.The patient did not develop any symptoms, adverse events, injuries, or require medical intervention as a result of the reported event.The machine was pulled from service for evaluation and it was determined the issue could not be replicated and no components were replaced.The bmt stated testing was performed on the machine and the parameters were all correct with no leaks found and re-calibration was not required.The bmt stated the machine was returned back in service without further issue.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• 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 ; +1(617)417-5172
• MDR Report Key: 25029638
• Report Number: 0008030665-2026-00812
• Device Sequence Number: 15984338
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: 191130
• 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: 04/24/2026
• Supplement Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 04/29/2026
• Supplement Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2025
• 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