MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 5008X HD/HDF - Standard Blood Tubing Set; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Catalog Number	03-5300-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/01/2026
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
A user facility¿s biomedical technician (bmt) reported that a fresenius 5008x bloodline leak during a patient¿s hemodialysis (hd) treatment.It is unknown if the machine alarmed appropriately the patient¿s estimated blood loss (ebl) is unknown.It is unknown if there was any patient serious injury or medical intervention required due to this event.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility¿s biomedical technician (bmt) reported that a fresenius 5008x bloodline leak during a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, alarmed appropriately with a ¿emb tray leak sensor¿ alarm.A fresenius dialyzer was also in use.There were no loose connections or issues during priming.There were no changes in pressure or blood flow rate (bfr) during treatment.There was no defect or damage noted on the bloodline.The patient¿s estimated blood loss (ebl) was approximately 100ml.The patient was restarted on the same machine and treatment completed successfully with new supplies.There was no patient serious injury or medical intervention required due to this event.The complaint device is available to be returned to the manufacturer for evaluation.Two photos have been provided.
Additional Manufacturer Narrative
Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.A visual inspection was conducted on the assembly of the main line, specifically at the connection to the red alpha clip where the leak was found.It was noted that the tubing showed presence of solvent in the assembly area; however, there was a slight separation between the wall of the main line and the wall of the red alpha clip port.Additionally, the assembly was not fully seated, leaving a visible gap.For further review, the main line was manually detached from the red alpha clip.No deformations were observed on the red alpha clip; however, the tubing assembly section confirmed that the tube had not been fully inserted into the red alpha clip.No other issues were found in the remaining components of the set.For the dimensional test, the main line was detached from the red alpha clip.The port entrance was measured using a pin gauge to verify its diameter against the required specifications.The measurement showed that the port entrance dimension were outside the acceptable tolerance range, indicating that the component does not meet specifications.Additionally, two photographs were received from the customer.In the photos, a leak can be confirmed from the assembly of the main line to the port of the red alpha clip.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.Upon completion of the evaluation, the reported event was confirmed.

• Brand Name: 5008X HD/HDF - Standard Blood Tubing Set
• Common Device Name: Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
• 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 ; +1(617)417-5172
• MDR Report Key: 25608705
• Report Number: 0008030665-2026-01401
• Device Sequence Number: 18592507
• Product Code: FJK
• UDI-Device Identifier: 00840861102518
• UDI-Public: 00840861102518
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K243505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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: 03-5300-3
• Device Lot Number: 26BR01183
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/12/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 06/30/2026; 09/25/2026
• Initial Report FDA Received Date: 06/24/2026
• Supplement Report FDA Received Date: 07/01/2026; 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS DIALYZER; FRESENIUS DIALYZER.; FRESENIUS HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE.; Fresenius Dialyzer; Fresenius Hemodialysis Machine
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 129 LB