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	Cardiac Arrest (1762)
Date of Event	01/01/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between home hemodialysis utilizing the 2008k2 hemodialysis machine and the patient event of cardiac arrest and death.However, there is no documentation to show a causal relationship between the adverse event and use of the 2008k2 machine.Additionally, there is no allegation of a machine malfunction or deficiency reported for this event.The patient was reportedly not feeling well during treatment prior to going into cardiac arrest.The patient¿s spouse did report that the patient had cardiac and other health issues.Cardiac arrest accounts for a quarter of deaths among patients on dialysis.The progression of cardiovascular diseases in dialysis patients is affected not only by traditional risk factors but also by other factors associated with uremia.Based on the limited information and no allegation or evidence of a malfunction or deficiency, the 2008k2 hemodialysis machine can be excluded as the cause of the patient¿s cardiac arrest and death.
Event or Problem Description
It was reported that a home hemodialysis (hd) patient was in treatment when they reported not feeling well (unspecified).The patient wanted to end the treatment.It was reported that the nurse wanted the patient to continue with the treatment.The patient then went into cardiac arrest.The patient was disconnected from the machine and passed away.It is believed that emergency medical services (ems) arrived at the patient¿s home and attempted to revive the patient.According to the patient¿s spouse, the patient had cardiac and other health issues.No alarms or issues were reported during the dialysis treatment.The date of the event was not provided.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 ; 6174175172
• MDR Report Key: 22107900
• Report Number: 0008030665-2025-01217
• Device Sequence Number: 8149859
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2010
• 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: Death
• Patient Sex: Male