MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number	190713
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 2008t hemodialysis (hd) machine's blood pump rotor sliced the blood pump tubing two hours into a patient's hd treatment.It was noted that blood was dripping from the blood pump tubing.The blood pump stopped and it was found that the blood pump had sliced approximately a half inch on the front surface of the tubing.Upon follow up, it was confirmed that the machine alarmed with an ¿air in blood¿ alarm.The patient¿s estimated blood loss (ebl) was 300 ml.It was confirmed that the patient required one unit of packed red blood cells (prbc).The patient was restarted on a new machine and treatment completed successfully with new supplies.The blood lines were discarded.The blood pump was inspected, deemed it acceptable to return to service and is in another machine.A new blood pump was put in the machine.The machine is back in service.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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: 24297412
• Report Number: 0008030665-2026-00269
• Device Sequence Number: 9415379
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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: 190713
• 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: 01/30/2026
• Initial Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2014
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CORAL DIALYZER.; FRESENIUS BLOODLINES.
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 110 KG