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	09/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
A user facility¿s clinic manager (cm) reported that a fresenius 5008x bloodline had air in the lines during a patient¿s hemodialysis (hd) treatment.The air originated from the arterial pressure dome.The machine, a fresenius 5008x machine, did not alarm, but was not expected to.The patient¿s estimated blood loss (ebl) was approximately 250ml.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.
Event or Problem Description
A user facility¿s clinic manager (cm) reported that a fresenius 5008x bloodline had air in the lines during a patient¿s hemodialysis (hd) treatment.The air originated from the arterial pressure dome.The machine, a fresenius 5008x machine, did not alarm, but was not expected to.The patient¿s estimated blood loss (ebl) was approximately 250ml.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.
Additional Manufacturer Narrative
Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During disinfection and preparation for analysis, the product was found to be in good condition: no bends, cracks, or other damage could be observed.A visual inspection was performed.Under microscopic examination a slight delamination was observed between the pressure dome port and the main line tubing however, no leak or detachment was presented from the assembly.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 not confirmed.

• 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: 23073641
• Report Number: 0008030665-2025-02223
• Device Sequence Number: 4966385
• 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): 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: 09/08/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 05/13/2026
• Initial Report FDA Received Date: 09/17/2025
• 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): 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 HEMODIALYSIS MACHINE; FRESENIUS HEMODIALYSIS MACHINE
• Patient Sex: Unknown