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	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A clinical manager (cm) reported to fresenius that a blood leak occurred during the patient's hemodialysis (hd) treatment.The reported issue was identified approximately 1.5 hours after treatment initiation.The patient care technician (pct) visually observed blood trickling down from the red alpha clip on the 5008x bloodlines.No defect or damage was noted to the bloodlines.Treatment was stopped.The patient was reinfused.The patient¿s estimated blood loss (ebl) was approximately 5 ml.No serious injury or required medical intervention resulted from the reported issue.Treatment continued with new supplies after the patient was transferred to a different machine.The sample was confirmed to have been returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Additional Manufacturer Narrative
Correction: e1 (facility name).
Event or Problem Description
A clinical manager (cm) reported to fresenius that a blood leak occurred during the patient's hemodialysis (hd) treatment.The reported issue was identified approximately 1.5 hours after treatment initiation.The patient care technician (pct) visually observed blood trickling down from the red alpha clip on the 5008x bloodlines.No defect or damage was noted to the bloodlines.Treatment was stopped.The patient was reinfused.The patient¿s estimated blood loss (ebl) was approximately 5 ml.No serious injury or required medical intervention resulted from the reported issue.Treatment continued with new supplies after the patient was transferred to a different machine.The sample was confirmed to have been returned to the manufacturer for physical evaluation.
Event or Problem Description
A clinical manager (cm) reported to fresenius that a blood leak occurred during the patient's hemodialysis (hd) treatment.The reported issue was identified approximately 1.5 hours after treatment initiation.The patient care technician (pct) visually observed blood trickling down from the red alpha clip on the 5008x bloodlines.No defect or damage was noted to the bloodlines.Treatment was stopped.The patient was reinfused.The patient¿s estimated blood loss (ebl) was approximately 5 ml.No serious injury or required medical intervention resulted from the reported issue.Treatment continued with new supplies after the patient was transferred to a different machine.The sample was confirmed to have been returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the sample was returned to the manufacturer for physical evaluation.During disinfection and preparation of the returned sample, a leak was found on the assembly from the red alpha clip to the main line.No additional abnormalities were identified upon further inspection.During the visual inspection it was noted that the tubing has 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 in the remaining components of the set.The reported issue was confirmed during the evaluation.The cause was determined to be an assembly issue.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.The entire lot has been sold and distributed.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.

• 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: 23877937
• Report Number: 0008030665-2025-03071
• Device Sequence Number: 9622918
• 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,Followup,Followup
• 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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2025
• Supplement Date Received by Manufacturer: 01/13/2026; 02/04/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/14/2026; 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: FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS MACHINE; FRESENIUS MACHINE; FRESENIUS MACHINE
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 75 KG