MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 5008X HD/HDF - STANDARD BLOOD TUBING SET; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

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	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility clinic manager (cm) reported approximately two hours into hemodialysis (hd) treatment, a clinician noticed blood leaking down from the alpha clip.Upon further inspection, blood was in fact leaking from connection at the clip.The patient was reinfused as there was no air in the lines.When lines were removed from machine, they completely disconnected at the alpha clip.Lines were saved and sent out for evaluation.Upon follow-up, the cm stated a patient was two hours into dialysis treatment on a fresenius 5008x machine when staff noticed blood leaking down from the alpha clip.Treatment was immediately halted.A fresenius fx coral 60 dialyzer was used for treatment and the patient's blood was successfully reinfused.The cm stated that the patient¿s estimated blood loss (ebl) was 30 cc.The cm confirmed there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The machine was not removed from the floor and remained in service.Following the event, the cm stated the patient was restarted on a different machine and treatment completed successfully with a new dialyzer and tubing lines without further issue.The complaint device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.The sample was received in packaging different from the standard configuration.The sample was disinfected in accordance with procedure.During disinfection and preparation for analysis, it was observed that the main arterial line connected to the alpha clip was detached.No additional abnormalities were identified upon further inspection.A visual inspection was performed.Under microscopic examination, solvent residue was detected at both the end of the tube and within the port of the alpha clip.No other issues were found in the remaining components of the set.The reported issue was confirmed during the evaluation.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.Upon completion of the evaluation, the reported event was confirmed.
Event or Problem Description
A user facility clinic manager (cm) reported approximately two hours into hemodialysis (hd) treatment, a clinician noticed blood leaking down from the alpha clip.Upon further inspection, blood was in fact leaking from connection at the clip.The patient was reinfused as there was no air in the lines.When lines were removed from machine, they completely disconnected at the alpha clip.Lines were saved and sent out for evaluation.Upon follow-up, the cm stated a patient was two hours into dialysis treatment on a fresenius 5008x machine when staff noticed blood leaking down from the alpha clip.Treatment was immediately halted.A fresenius fx coral 60 dialyzer was used for treatment and the patient's blood was successfully reinfused.The cm stated that the patient¿s estimated blood loss (ebl) was 30 cc.The cm confirmed there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The machine was not removed from the floor and remained in service.Following the event, the cm stated the patient was restarted on a different machine and treatment completed successfully with a new dialyzer and tubing lines without further issue.The complaint device was returned to the manufacturer for evaluation.

• Brand Name: 5008X HD/HDF - STANDARD BLOOD TUBING SET
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 23439615
• Report Number: 0008030665-2025-02617
• Device Sequence Number: 20965851
• Product Code: KOC
• UDI-Device Identifier: 00840861102518
• UDI-Public: 00840861102518
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231534
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2025

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: 03-5300-3
• Device Lot Number: 25KR01224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/13/2025
• 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 5008X MACHINE.; FRESENIUS 5008X MACHINE.; FRESENIUS FX CORAL 60 DIALYZER.; FRESENIUS FX CORAL 60 DIALYZER.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 59 KG