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	01/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility registered nurse (rn) reported that a blood leak occurred during a patient¿s hemodialysis (hd) treatment.The leak was coming from the blood pump tubing segment of a 5008x bloodline.Additional details were provided upon follow-up with the facility.The blood leak was not noticed until after the patient's treatment was completed.A t the end of the treatment when the supplies were being taken down, drops of blood were identified on the blood pump.The rn said there were no alarms from the 5008x machine during the treatment.The rn said there were no known issues throughout the duration of the treatment.There were no loose connections noted, and no leaks noticed during the prime.No visible defects were noticed on the bloodlines.The rn said blood loss was minimal.The patient's estimated blood loss (ebl) due to the leak was about 2 ml.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.Patient details were unable to be provided.The bloodlines were sent back for manufacturer evaluation.
Additional Manufacturer Narrative
Plant investigation: the complaint sample was returned to the manufacturer for physical evaluation.The sample was received without its original packaging.As the sample was being disinfected and prepared for analysis, a leak was found on the assembly from the pump tubing to the red alpha clip.A visual inspection was performed on the assembly of the pump tubing, 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 pump 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.

• 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: 24274290
• Report Number: 0008030665-2026-00251
• Device Sequence Number: 18822211
• Product Code: FJK
• UDI-Device Identifier: 00840861102518
• UDI-Public: 00840861102518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/05/2026

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: 01/21/2026
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 02/05/2026
• 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 Sex: Unknown