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	12/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the complaint sample was returned to the manufacturer for physical evaluation.The sample was received in packaging different from the standard configuration.As the sample was being disinfected and prepared for analysis, a leak was found on the assembly of the arterial main line to the red alpha clip.A visual inspection was performed of the arterial main line assembly, and more specifically, at the connection to the red alpha clip.The tubing had a presence of solvent, however, there was a delamination from the wall of the main line tubing to the wall of the red alpha clip port.No other issues were found with the remaining components of the set.There are several potential causes for this kind of failure.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.A product history review did not reveal a probable cause for the customer complaint.The investigation into the complaint was able to confirm the reported event.
Event or Problem Description
A user facility clinical manager (cm) reported that a 5008x standard blood tubing set blood leak occurred three and a half hours into a patient¿s hemodialysis (hd) treatment.The blood leak was reportedly coming from the alpha clip on the tubing set.None of the connections appeared to be loose leading up to the event.However, the tubing completely separated at the leak location.There were no machine alarms that occurred.The bloodlines were inspected for defects prior to use with no anomalies noted.There was a visible, unspecified defect noted after the leak occurred.There were no leaks during the priming/setup.Additionally, there were no changes or disruptions in pressure that could have contributed to the leak.The patient¿s blood was able to be reinfused without issue.Estimated blood loss (ebl) due to the leak was approximately 30ml.The cm 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 patient did not complete their full treatment.Treatment was not restarted because the dialysis session was almost over.The sample was sent back for manufacturer evaluation.

• 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 ; 6174175172
• MDR Report Key: 24111211
• Report Number: 0008030665-2026-00124
• Device Sequence Number: 16050831
• Product Code: FJK
• UDI-Device Identifier: 00840861102518
• UDI-Public: 00840861102518
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/19/2026

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: 25KR01224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2025
• 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: 5008X HEMODIALYSIS MACHINE; FX CORAL DIALYZER
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 65 KG