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	01/08/2026
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 red alpha clip to the main arterial line; however, a complete detachment of the tubing from the red alpha connector could not be confirmed.A visual inspection was performed on the returned sample.Under microscopic examination, a delamination was observed on the wall of the main line assembled to the red alpha clip.After further inspection, no other issues were found with the remaining components of the set.The reported issue was confirmed based on the evaluation.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-conformance's 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 returned a 5008x bloodline to the manufacturing plant for evaluation.On the form provided with the returned sample, it was reported that the alpha clip came out, and blood leaked onto the front of the machine.It was reported that this happened during the rinse back phase of a patient¿s hemodialysis (hd) treatment.Additional details were provided upon follow-up with the clinical manager (cm) from the user facility.A complete separation did not occur on the bloodlines.It was unknown if any machine alarms occurred.The lines were noted to be free of defects prior to use.There was a visible defect noted after the leak.Per staff, there appeared to be a small split in the line.There was no leak noted during prime or setup, and there was no change or disruption in pressure.The blood leak resulted in approximately 3-5 ml of blood loss.The patient did not experience any adverse reactions/events or require medical intervention.No further treatment was needed.A photo was provided by the cm depicting where the blood was dripping from.

• 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: 24370099
• Report Number: 0008030665-2026-00340
• Device Sequence Number: 9782307
• Product Code: FJK
• UDI-Device Identifier: 00840861102532
• UDI-Public: 00840861102532
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 02/17/2026

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: 03-5300-3C
• Device Lot Number: 25JR01801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2026
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/17/2026
• 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: 5008X HEMODIALYSIS MACHINE.; FX CORAL DIALYZER.
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 60 KG