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	10/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility clinic manager (cm) reported a 5008x hemodialysis (hd) machine prompted with air detect near arterial port alarms during treatment.The air in bloodlines alarm was resolved per policy; however the alarm kept returning.Clinicians tried to reinfuse patient in order to set up new bloodlines, and could not successfully do so.Bloodlines were sent back for evaluation.Upon follow-up, the cm stated a patient was one hour a thirty minutes into dialysis treatment on a fresenius 5008x machine when the machine prompted an alarm indicating air detected near the arterial port alarms.Treatment was halted and the staff was unable to locate a leak or damage to the blood tubing set.A fresenius fx coral 80 dialyzer was used for treatment and the patient's blood was unable to be reinfused.The cm stated that the patient¿s estimated blood loss (ebl) was 250 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 has 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 bloodlines without further issue.The complaint device was returned to the manufacturer for evaluation.
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 a 5008x hemodialysis (hd) machine prompted with air detect near arterial port alarms during treatment.The air in bloodlines alarm was resolved per policy; however the alarm kept returning.Clinicians tried to reinfuse patient in order to set up new bloodlines, and could not successfully do so.Bloodlines were sent back for evaluation.Upon follow-up, the cm stated a patient was one hour a thirty minutes into dialysis treatment on a fresenius 5008x machine when the machine prompted an alarm indicating air detected near the arterial port alarms.Treatment was halted and the staff was unable to locate a leak or damage to the blood tubing set.A fresenius fx coral 80 dialyzer was used for treatment and the patient's blood was unable to be reinfused.The cm stated that the patient¿s estimated blood loss (ebl) was 250 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 has 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 bloodlines 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 open with its original packaging.The sample was disinfected in accordance with procedure.As the complaint product sample was being disinfected and prepared for analysis, no leak nor any problem was found in the set.A visual inspection was performed, during the inspection under the microscope no problems were found on the assembly from the main line to the pressure dome, no gaps, separation, delamination neither other problem was found.The product was in the expected condition.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 not confirmed.

• 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: 23439296
• Report Number: 0008030665-2025-02612
• Device Sequence Number: 4759092
• 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,Followup
• Report Date (Section B): 06/01/2026

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: 25JR01800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 05/13/2026
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 11/13/2025; 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• 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 CORAL 80 DIALYZER.; FRESENIUS CORAL 80 DIALYZER.
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 102 KG