MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Catalog Number	190610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dizziness (2194); Insufficient Information (4580)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hd therapy utilizing a 2008k2 hemodialysis system and the serious adverse event(s) of a code blue.It should be noted that limited follow-up clinical information precluded a more comprehensive investigation.However, based on the initial reporting of the serious adverse events, there was no report of a fresenius device malfunction or deficiency.Per the biomedical technician, post-event testing was ordered and completed per the company¿s protocol.Additionally, the 2008k2 hemodialysis system passed all post-event functional and ultrafiltration testing.Given the high comorbidity burden in patients on hd and the complexity of the dialysis treatment, it is remarkable how few major complications occur.Most hd emergencies can be attributed to human error, and a smaller number are due to rare idiosyncratic reactions.Based on the information available, the 2008k2 hemodialysis system can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device and/or product caused or contributed to the serious adverse events.Furthermore, there is no report a fresenius device failed to meet the users¿ expectations and/or the manufacturers¿ specifications.
Event or Problem Description
A user facility biomedical technician reported that a hemodialysis (hd) patient experienced a ¿code blue¿ (specifics not provided) after completing hd therapy on a 2008k2 hd machine.The patient reportedly completed treatment, and upon standing/ambulating the patient became dizzy.The patient was ¿sat down¿ and shortly thereafter the code blue occurred.The biomedical technician stated there were no device issues or anything unusual noted during treatment.The 2008k2 hd machine was sequestered following the serious adverse event(s), and a fresenius field service technician (fst) was dispatched to perform post-event functional compliance testing (per company protocol).The device passed all functional compliance and ultrafiltration testing (e.G., self-tests, conductivity, temperature, ph, ultrafiltration pump, fluid removal), however it is currently unknown if the machine was returned to service.Multiple attempts were made to obtain additional information, and thus far no further details have been provided.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 22181415
• Report Number: 0008030665-2025-01313
• Device Sequence Number: 8588808
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K153449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: Yes
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 07/14/2026
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2009
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown