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	09/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's biomedical technician (bmt) reported that a fresenius 5008x bloodline was missing the blue clamp and had air in the line during a patient¿s hemodialysis (hd) treatment.The machine, a 5008x hemodialysis (hd) machine alarmed appropriately with an "air detected below venous chamber" alarm.Air was visible in the line below the venous chamber.The patient's blood was not returned following the incident.The patient¿s estimated blood loss (ebl) is unknown.It was reported at intake that there was no patient serious injury or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.It is unknown if the complaint device is available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: b5, d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During disinfection and preparation for analysis, no leaks nor any additional abnormalities were identified upon further inspection.A visual inspection was performed and revealed that the blue clamp assembled from the venous main line to the chamber was missing.No other issues were found in the remaining components of the set.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's biomedical technician (bmt) reported that a fresenius 5008x bloodline was missing the blue clamp and had air in the line during a patient¿s hemodialysis (hd) treatment.The machine, a 5008x hemodialysis (hd) machine alarmed appropriately with an "air detected below venous chamber" alarm.Air was visible in the line below the venous chamber.The patient's blood was not returned following the incident.The patient¿s estimated blood loss (ebl) is unknown.It was reported at intake that there was no patient serious injury or medical intervention required as a result of this event.The patient was restarted on a new machine and treatment completed successfully with new supplies.The complaint device is available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.

• 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: 23156216
• Report Number: 0008030665-2025-02297
• Device Sequence Number: 10154279
• 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: K231534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2026

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
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 05/13/2026
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/11/2025; 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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 HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.
• Patient Sex: Unknown