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	08/25/2025
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
It was reported to fresenius that the blood pump rotor on the 2008t machine damaged the blood pump housing during a patient's hemodialysis (hd) treatment and resulted in blood loss.A cap came off and exposed the guide pin which perforated the bloodline.A nurse stated during follow-up that the clinic staff visually observed the reported issue.Droplets were identified that the clinic staff determined were coming from a hole in the bloodlines caused from the 2008t machine blood pump.The patient¿s estimated blood loss (ebl) was not quantified.No serious injury or required medical intervention resulted from the reported issue.The patient completed treatment on the reported event date with the same machine after the blood pump rotor was immediately replaced.Fresenius supplies were not used for this treatment.The machine remains in the back room as a potential backup to be returned to service at any time.The sample will be returned to the manufacturer for physical evaluation.No additional information is available.
Additional Manufacturer Narrative
Correction: a3 (gender) the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported to fresenius that the blood pump rotor on the 2008t machine damaged the blood pump housing during a patient's hemodialysis (hd) treatment and resulted in blood loss.A cap came off and exposed the guide pin which perforated the bloodline.A nurse stated during follow-up that the clinic staff visually observed the reported issue.Droplets were identified that the clinic staff determined were coming from a hole in the bloodlines caused from the 2008t machine blood pump.The patient¿s estimated blood loss (ebl) was not quantified.No serious injury or required medical intervention resulted from the reported issue.The patient completed treatment on the reported event date with the same machine after the blood pump rotor was immediately replaced.Fresenius supplies were not used for this treatment.The machine remains in the back room as a potential backup to be returned to service at any time.The sample will be returned to the manufacturer for physical evaluation.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: although it was stated that the complaint device was available to be returned, to date 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 found objective evidence indicating a product problem, thus the complaint is confirmed.
Event or Problem Description
It was reported to fresenius that the blood pump rotor on the 2008t machine damaged the blood pump housing during a patient's hemodialysis (hd) treatment and resulted in blood loss.A cap came off and exposed the guide pin which perforated the bloodline.A nurse stated during follow-up that the clinic staff visually observed the reported issue.Droplets were identified that the clinic staff determined were coming from a hole in the bloodlines caused from the 2008t machine blood pump.The patient¿s estimated blood loss (ebl) was not quantified.No serious injury or required medical intervention resulted from the reported issue.The patient completed treatment on the reported event date with the same machine after the blood pump rotor was immediately replaced.Fresenius supplies were not used for this treatment.The machine remains in the back room as a potential backup to be returned to service at any time.The sample will be returned to the manufacturer for physical evaluation.No additional information is available.

• 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: 22938169
• Report Number: 0008030665-2025-02076
• Device Sequence Number: 18615119
• Product Code: KDI
• UDI-Device Identifier: 00840861102112
• UDI-Public: 00840861102112
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2026

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: 191130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 09/02/2025; 12/04/2025; 05/13/2026
• Initial Report FDA Received Date: 09/02/2025
• Supplement Report FDA Received Date: 09/02/2025; 12/05/2025; 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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
• Patient Sex: Female