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	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s registered nurse (rn) reported that a fresenius 5008x bloodline leaked one and a half hours after the initiation of a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the bloodline.A fresenius dialyzer was also in use.There were no changes to pressure or blood flow rate during treatment.There were no issues during priming.The patient¿s estimated blood loss (ebl) was approximately 300ml.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 was reported to be 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, a leak was found on the assembly from the pump tubing to the red alpha clip.A visual inspection found no damage on the product.However, an additional inspection was performed on the assembly of the pump tubing, specifically at the connection to the red alpha clip.During the visual inspection it was found that the tubing had solvent present, however there was a delamination from the wall of the pump 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.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.
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 registered nurse (rn) reported that a fresenius 5008x bloodline leaked one and a half hours after the initiation of a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the bloodline.A fresenius dialyzer was also in use.There were no changes to pressure or blood flow rate during treatment.There were no issues during priming.The patient¿s estimated blood loss (ebl) was approximately 400ml.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 was reported to be available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility¿s registered nurse (rn) reported that a fresenius 5008x bloodline leaked one and a half hours after the initiation of a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the bloodline.A fresenius dialyzer was also in use.There were no changes to pressure or blood flow rate during treatment.There were no issues during priming.The patient¿s estimated blood loss (ebl) was approximately 300ml.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 was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Corrected information: b5 the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During disinfection and preparation for analysis, a leak was found on the assembly from the arterial main line to the red alpha clip.A visual inspection was conducted and no damage was observed.However, an additional inspection was performed on the assembly of the pump tubing, specifically at the connection to the red alpha clip.During the visual inspection the presence of solvent was found on the tubing, however, there was a delamination from the wall of the pump 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.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 registered nurse (rn) reported that a fresenius 5008x bloodline leaked one and a half hours after the initiation of a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the bloodline.A fresenius dialyzer was also in use.There were no changes to pressure or blood flow rate during treatment.There were no issues during priming.The patient¿s estimated blood loss (ebl) was approximately 300ml.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 was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
No additional information is available.This follow up mdr report was inadvertently generated.
Event or Problem Description
A user facility¿s registered nurse (rn) reported that a fresenius 5008x bloodline leaked one and a half hours after the initiation of a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, alarmed appropriately with a blood leak alarm.There was no defect or damage noted on the bloodline.A fresenius dialyzer was also in use.There were no changes to pressure or blood flow rate during treatment.There were no issues during priming.The patient¿s estimated blood loss (ebl) was approximately 300ml.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 was reported to be available to be returned to the manufacturer for evaluation.

• 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: 24003810
• Report Number: 0008030665-2026-00055
• Device Sequence Number: 18741625
• 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,Followup,Followup
• Report Date (Section B): 02/10/2026

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: 01/07/2026
• Supplement Date Received by Manufacturer: 01/08/2026; 01/13/2026; 01/30/2026; 02/10/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 01/08/2026; 01/14/2026; 02/02/2026; 02/10/2026
• 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 DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 86 KG