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

Catalog Number	191126
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported that a blood pump rotor on a 2008t hemodialysis (hd) machine cut the tubing of a combiset bloodline during a patient¿s hd treatment.Additional details were provided upon follow-up with the biomed and a registered nurse (rn) familiar with the event.Approximately one hour after the start of treatment, the rn noticed a clicking noise coming from the machine.They traced the noise to the blood pump rotor.The rn then noticed a small amount of blood leaking from the blood pump.There were no machine alarms that occurred.The rn stopped the blood pump and the patient was disconnected from the machine.The rn did not inspect the bloodline following the event.They said they focused their attention on the safety of the patient.The rn said there was no visible damage noted on the lines prior to treatment initiation.The patient's blood was not returned.Estimated blood loss (ebl) due to the event was reported to be 200 ml.The patient was able to complete their treatment after being re-setup with new supplies on a different machine.The rn confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The machine involved in the blood loss event was removed from service for evaluation.The biomed was able to fix the machine by replacing the blood pump rotor.The biomed said that one of the white caps on the rotor pins was not secure.The biomed said it was loose and slightly cracked.The faulty rotor was not available to be sent back for evaluation.The machine was returned to service upon completion of the repair.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility biomedical technician (biomed) reported that a blood pump rotor on a 2008t hemodialysis (hd) machine cut the tubing of a combiset bloodline during a patient¿s hd treatment.Additional details were provided upon follow-up with the biomed and a registered nurse (rn) familiar with the event.Approximately one hour after the start of treatment, the rn noticed a clicking noise coming from the machine.They traced the noise to the blood pump rotor.The rn then noticed a small amount of blood leaking from the blood pump.There were no machine alarms that occurred.The rn stopped the blood pump and the patient was disconnected from the machine.The rn did not inspect the bloodline following the event.They said they focused their attention on the safety of the patient.The rn said there was no visible damage noted on the lines prior to treatment initiation.The patient's blood was not returned.Estimated blood loss (ebl) due to the event was reported to be 200 ml.The patient was able to complete their treatment after being re-setup with new supplies on a different machine.The rn confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The machine involved in the blood loss event was removed from service for evaluation.The biomed was able to fix the machine by replacing the blood pump rotor.The biomed said that one of the white caps on the rotor pins was not secure.The biomed said it was loose and slightly cracked.The faulty rotor was not available to be sent back for evaluation.The machine was returned to service upon completion of the repair.
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).However, the complaint investigation found objective evidence indicating a product problem, and thus the complaint was confirmed.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.Based on the available information, the reported event has been confirmed.

• Brand Name: 2008T HD SYS. 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: 24273012
• Report Number: 0008030665-2026-00244
• Device Sequence Number: 10031082
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2026

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: 191126
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2024
• 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: FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 113 KG