MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 5008X HD/HDF With CLiC Blood Tubing Set; Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

Catalog Number	03-5300-3C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility¿s facility administrator (fa)) reported that a fme 5008x bloodline leaked two hours after the initiation of a patient¿s hemodialysis (hd) treatment.The machine, a 5008x hd machine, alarmed appropriately.Blood leak test strips were used and tested positive for the presence of blood.A fme coral dialyzer was in use.The leak originated from the ¿t¿ connection of the arterial line and the heparin line.There were no issues during priming and no loose connections.There was no change in pressure or blood flow rate during treatment.The patient¿s estimated blood loss (ebl) is 50ml.The patient chose not to complete treatment following the issue.There was no patient injury or medical intervention required due to the reported event.The complaint device is available to be returned to the manufacturer for evaluation.Four photos were provided.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: 5008X HD/HDF With CLiC 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 ; +1(617)417-5172
• MDR Report Key: 50927012
• Report Number: 0008030665-2026-02590
• Device Sequence Number: 9734237
• Product Code: FJK
• UDI-Device Identifier: 00840861102532
• UDI-Public: 00840861102532
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: 03-5300-3C
• Device Lot Number: 26HR01280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2026
• 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: 5008X Hemodialysis Machine; Coral Dialyzer
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 147 LB