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	01/19/2026
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 leaked during a patient¿s hemodialysis (hd) treatment.The leak originated from the alpha clip near the blood pump.The patient¿s estimated blood loss (ebl) is 20ml.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.
Event or Problem Description
A user facility¿s registered nurse (rn) reported that a fresenius 5008x bloodline leaked three hours and twenty minutes after the initiation of a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, did not alarm, but is not expected to.A fresenius dialyzer was also in use.The leak originated from a disconnection where the alpha clip meets the bloodline.No issues were noted during priming.There were no changes in pressure or blood flow rate during treatment.The patient¿s estimated blood loss (ebl) was approximately 20ml.There was no patient serious injury or medical intervention required as a result of this event.The patient was not restarted because there was only ten minutes left in their scheduled treatment time.The patient did not experience any issues as a result of ending treatment early.The complaint device was returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Additional information: a1, a2, a3, a4, b5, d10 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.As the complaint product sample was being disinfected and prepared for analysis, a leak was found at the assembly of the red alpha clip to the pump tube.After further inspection, no other abnormalities were found.A visual inspection was performed and found a delamination on the wall of the pump tube assembled to the red alpha clip.After further inspection, 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 three hours and twenty minutes after the initiation of a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 5008x machine, did not alarm, but is not expected to.A fresenius dialyzer was also in use.The leak originated from a disconnection where the alpha clip meets the bloodline.No issues were noted during priming.There were no changes in pressure or blood flow rate during treatment.The patient¿s estimated blood loss (ebl) was approximately 20ml.There was no patient serious injury or medical intervention required as a result of this event.The patient was not restarted because there was only ten minutes left in their scheduled treatment time.The patient did not experience any issues as a result of ending treatment early.The complaint device was 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: 24178159
• Report Number: 0008030665-2026-00173
• Device Sequence Number: 15842110
• 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): 02/05/2026

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: 25KR01224
• 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: 01/19/2026
• Supplement Date Received by Manufacturer: 01/28/2026; 02/04/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 01/28/2026; 02/05/2026
• 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 DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 58 KG