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 Code	Insufficient Information (4580)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy utilizing a 2008k2 hemodialysis system and the serious adverse events of a loss of consciousness due to intradialytic hypotension, which required the termination of hd therapy and the administration of a vasopressor for blood pressure support.Intradialytic hypotension is the most prevalent complication associated with hd, occurring in approximately 25% of all treatments.Very often, the cause of intradialytic hypotension is multifactorial in origin.Per the icn, the serious adverse events were unrelated to any fresenius device and/or product malfunction or deficiency.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 the serious adverse events.Furthermore, there was no report a fresenius product and/or device failed to meet the users¿ expectations and/or the manufacturers¿ specifications during post-event functional compliance testing.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
On 25/mar/2025, fresenius became aware this female patient with renal failure (rf) on hemodialysis (hd) utilizing a 2008k2 hemodialysis system for renal replacement therapy (rrt) encountered a medical event during hd therapy on (b)(6) 2025, which required a ¿rapid response¿ call for additional medical staff.During follow-up, the inpatient charge nurse (icn) on (b)(6) 2025, reported the rapid response call was not due to a cardiopulmonary arrest, but rather a loss of consciousness due to an episode of intradialytic hypotension (specifics not provided).The patient was placed on an intravenous (iv) vasopressor (drug, dose, duration, frequency not provided) for blood pressure support, and dialysis was discontinued for the remainder of the day.The patient stabilized after the serious adverse events and resumed hd therapy the following day.As of (b)(6) 2025, the patient remains hospitalized, however her current disposition was not provided.The 2008k hemodialysis system was sequestered following the serious adverse events.On 28/mar/2025, a fresenius field service technician (fst) was dispatched to perform post-event functional compliance testing.The device passed all functional compliance testing (e.G., self-tests, conductivity, temperature, ph, ultrafiltration pump), despite encountering a leak during the disinfection/rinse cycle (repaired tubing connection at the uf sample port).Following the repair, the 2008k2 hemodialysis system did not require any further repair or calibration and was returned to service.

• 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 ; 6174175172
• MDR Report Key: 21752541
• Report Number: 0008030665-2025-00745
• Device Sequence Number: 8220695
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2010
• 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; Hospitalization; Life Threatening
• Patient Sex: Female