MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 5008X HD/HDF WITH CLIC BLOOD TUBING SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-5300-3C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the sample was returned to the manufacturer for physical evaluation.The sample was received in packaging different from the standard configuration.The sample was disinfected.During disinfection and preparation for analysis, a leak was found on the assembly from the arterial main line to the red alpha clip.Under microscopic examination it was observed that on the assembly from the main line tubing and the red alpha clip, there was a tiny separation from the wall of the tubing and the wall of the red alpha clip port.The tubing has solvent present.After further review, it was found that the tubing was not fully adhered to the port of the red alpha clip.The reported issue was confirmed.The manufacturer determined improper assembly during the manufacturing process as a probable cause for this issue.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.
Event or Problem Description
The facility administrator (fa) reported to fresenius that blood dripped out of the alfa clip of the blood pump of the 5008x bloodlines during a patient's hemodialysis (hd) treatment.Additional information was obtained during follow-up.The fa stated that only a drop of blood was noted.The patient¿s estimated blood loss (ebl) was not provided.No serious injury or required medical intervention resulted from the reported issue.The patient was reinfused and transferred to a different machine where treatment was completed with new supplies.The fa did not inspect the bloodlines nor was it reported to them that any defect or damage was noted to the product.The sample was reported to be available to be returned to the manufacturer for physical evaluation.

• Brand Name: 5008X HD/HDF WITH CLIC 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 ; 6174175172
• MDR Report Key: 23524570
• Report Number: 0008030665-2025-02712
• Device Sequence Number: 18648637
• Product Code: FJK
• UDI-Device Identifier: 00840861102532
• UDI-Public: 00840861102532
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2025

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: 03-5300-3C
• Device Lot Number: 25JR01801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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 5008X MACHINE; FRESENIUS CORAL DIALYZER
• Patient Sex: Unknown