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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	11/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility biomedical technician (biomed) reported to fresenius that the patient coded during treatment on the 2008t machine.No further information regarding the treatment was available.The biomed stated the patient passed away at the hospital two days later.No further details about the patient were provided despite several follow-up attempts.The customer requested (per hospital policy) an onsite visit for a device evaluation by a fresenius field service technician (fst).The fst documented in their service report that the fresenius 2008t machine passed all functional testing.
Additional Manufacturer Narrative
Clinical review: a temporal relationship exists between the fresenius 2008t machine and the event of patient code with subsequent death 2 days later.Due to very limited information, a thorough clinical investigation cannot be carried out.At this time, it is unknown what caused/contributed to the patient code.Currently, there is no documentation that a malfunction or product issue with the fresenius 2008 t machine caused this event to occur.However, due to temporal association, the fresenius 2008 t machine cannot be completely excluded.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The complaint investigation did not find objective evidence indicating a product problem; thus, the complaint is unconfirmed.
Event or Problem Description
The user facility biomedical technician (biomed) reported to fresenius that the patient coded during treatment on the 2008t machine.No further information regarding the treatment was available.The biomed stated the patient passed away at the hospital two days later.No further details about the patient were provided despite several follow-up attempts.The customer requested (per hospital policy) an onsite visit for a device evaluation by a fresenius field service technician (fst).The fst documented in their service report that the fresenius 2008t machine passed all functional testing.

• 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 ; 6174175172
• MDR Report Key: 23582769
• Report Number: 0008030665-2025-02789
• Device Sequence Number: 15797229
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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): 12/05/2025

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: 191130
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2022
• 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; Death; Required Intervention
• Patient Sex: Unknown