MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. CUSTOM COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-2742-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/20/2025
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 registered nurse (rn) reported that a bloodline leaked immediately after the initiation of a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed due to a separation between the medication administration line and the venous chamber.A fresenius dialyzer was also in use.The patient¿s estimated blood loss (ebl) was approximately 300ml.There was no patient injury or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with a new bloodline.The complaint device is available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.During the disinfection, a leak was found on the venous chamber due a separation from the top cap to the bottom chamber.The complaint product sample was visually inspected and it was found that the top of the venous chamber was not assembled properly causing a separation.During the inspection with the microscope, it was found that there was no presence of solvent between assembly of the venous chamber and the top cap.The reported event was confirmed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformance's 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 bloodline leaked immediately after the initiation of a patient¿s hemodialysis (hd) treatment.The blood leak was visually observed due to a separation between the medication administration line and the venous chamber.A fresenius dialyzer was also in use.The patient¿s estimated blood loss (ebl) was approximately 300ml.There was no patient injury or medical intervention required as a result of this event.The patient successfully completed treatment on the same machine with a new bloodline.The complaint device is available to be returned to the manufacturer for physical evaluation.

• Brand Name: CUSTOM COMBI 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: 21493830
• Report Number: 0008030665-2025-00484
• Device Sequence Number: 15590173
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K962081
• 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
• Report Date (Section B): 07/28/2025

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: 03-2742-9
• Device Lot Number: 24SR01021
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 02/28/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2024
• 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 BLOODLINES.; FRESENIUS BLOODLINES.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 73 KG