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 Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electrolyte Imbalance (2196)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: a temporal relationship exists between hemodialysis treatment with the fresenius 2008 t machine and the patient¿s drop in potassium (hypokalemia).Electrolyte imbalance is a common finding in patients with end stage renal disease due to the pathophysiological loss of kidney function.Typically, the dialysate bath concentration is lower than the serum concentration of potassium which allows for artificial filtration and removal of excess serum potassium during hemodialysis.Given the reported information, there is no allegation or objective evidence that a 2008 t machine malfunction caused this event.Rather, the patient has a reported preexisting history of hypokalemia with hemodialysis and therefore the event is likely to be related to patient physiology in the setting of expected filtration of potassium during hemodialysis.
Event or Problem Description
On 23/oct/2025, it was reported to technical support by a biomedical technician (bmt) that a fresenius 2008 t machine was not holding date and time.Technical support advised to swap the sram on the function board and provided part number.During the call, the bmt also stated that a patient receiving hemodialysis in the hospital experienced a drop in potassium (result 3 meq/l) during hemodialysis treatment with the fresenius 2008 t machine (serial number (b)(6)) with a dialysate bath of 2k and 2.5k.Technical support advised that a drop in potassium is an expected finding.There were no allegations against the dialysate bath.The bmt could not confirmed if the patient required medical intervention for hypokalemia.However, it was reported that the patfient was able to complete the hemodialysis treatment with the 2008 t machine.The bmt stated that out of precaution the machine was pulled from service and put through functional testing.According to the bmt, the machine passed all functional testing post event (despite machine date/time issue) and was returned to service.The bmt stated that it was also discovered that this patient has a history of hypokalemia and that this event was coincidental in nature.Per the bmt, there is no allegation that the machine¿s date and time issue caused the patient¿s hypokalemia.

• 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 ; +1(617)417-5172
• MDR Report Key: 23546858
• Report Number: 0008030665-2025-02750
• Device Sequence Number: 9683316
• Product Code: KDI
• UDI-Device Identifier: 00840861100910
• UDI-Public: 00840861100910
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: Other
• Device Catalogue Number: 190766
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2017
• 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: Hospitalization
• Patient Sex: Unknown