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	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: on february 19, 2026, reynosa received one complaint product sample from product code 03-5300-3c, lot number 25sr01805.The sample was received in packaging different from the standard configuration.The sample was disinfected in accordance with procedure.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.No damage was observed on the product during this inspection.However, an additional inspection was performed on the assembly of the arterial main line, specifically at the connection to the red alpha clip.During the visual inspection with the microscope, it was found that the tubing has presence of solvent, however, there was a delamination from the wall of the main line 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.Potential root causes: the observed damage may be attributed to improper assembly during the manufacturing process.Possible contributing factors include: incorrect assembly technique, unqualified operator, inadequate or unclear work instructions, malfunctioning dispensers during assembly, insufficient solvent in dispenser, incorrect dispenser configuration, improper solvent application technique, failure to follow applicable work instructions.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.The complaint was confirmed.
Event or Problem Description
A user facility clinic manager (cm) reported a circuit leak.The machine did not alarm.Blood did not get noticed until doors were opened during rinse back.The estimated blood loss (ebl) was unknown.Additional information was requested but was not received to date.
Event or Problem Description
A user facility clinic manager (cm) reported a circuit leak.The machine did not alarm.Blood did not get noticed until doors were opened during rinse back.The estimated blood loss (ebl) was unknown.Additional information was requested but was not received to date.
Additional Manufacturer Narrative
Correction: h10 plant investigation: on (b)(6) 2026, reynosa received one complaint product sample from product code 03-5300-3c, lot number 25sr01805.The sample was received in packaging different from the standard configuration.The sample was disinfected in accordance with procedure.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.No damage was observed on the product during this inspection.However, an additional inspection was performed on the assembly of the arterial main line, specifically at the connection to the red alpha clip.During the visual inspection with the microscope, it was found that the tubing has presence of solvent, however, there was a delamination from the wall of the main line 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.Possible root causes: disposable manufactured with a leak.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.The complaint was confirmed.

• 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 ; 6174175172
• MDR Report Key: 24518544
• Report Number: 0008030665-2026-00442
• Device Sequence Number: 9723683
• Product Code: FJK
• UDI-Device Identifier: 00840861102532
• UDI-Public: 00840861102532
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2026

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: 25SR01805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2025
• 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 Sex: Unknown