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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
The biomedical technician (biomed) for a user facility reported to fresenius technical services that the bloodline tubing was punctured by the 2008t machine blood pump rotor during the patient's hemodialysis (hd) treatment resulting in blood loss.The patient care technician (pct) notified the biomed of the reported issue.Droplets were visually observed running down the front of the machine.The patient's blood was not returned.The patient's estimated blood loss (ebl) was not provided.No serious injury or required medical intervention resulted from the reported issue.The biomed advised the pct to transfer the patient to a different machine where treatment was successfully completed.The machine was removed from service following the reported event.A replacement blood pump rotor was ordered via ground shipping.The machine remains out of service pending repair.No parts were reported to be returned to the manufacturer for physical evaluation.Additional information was requested, however a response was not received.
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 biomedical technician (biomed) for a user facility reported to fresenius technical services that the bloodline tubing was punctured by the 2008t machine blood pump rotor during the patient's hemodialysis (hd) treatment resulting in blood loss.The patient care technician (pct) notified the biomed of the reported issue.Droplets were visually observed running down the front of the machine.The patient's blood was not returned.The patient's estimated blood loss (ebl) was not provided.No serious injury or required medical intervention resulted from the reported issue.The biomed advised the pct to transfer the patient to a different machine where treatment was successfully completed.The machine was removed from service following the reported event.A replacement blood pump rotor was ordered via ground shipping.The machine remains out of service pending repair.No parts were reported to be returned to the manufacturer for physical evaluation.Additional information was requested, however a response was not received.

• 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: 23478417
• Report Number: 0008030665-2025-02662
• Device Sequence Number: 10237579
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 191130
• 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: 10/23/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• 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
• Patient Sex: Unknown