MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET ACCESS FLOW REVERSE CON TWISTER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number	03-2794-0
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/02/2025
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 clinic manager (cm) reported that a fresenius bloodline leaked fifteen minutes into a patient¿s hemodialysis (hd) treatment.The leak was due to faulty twist lines that had not yet been switched for access testing.The machine, a fresenius 2008t machine, did not alarm, but was not expected to.A fresenius dialyzer was also in use.There were no loose connections, changes in pressure and no damage was seen on the bloodline.The patient¿s estimated blood loss (ebl) was approximately 50ml.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.The manufacturing facility received a product complaint sample open with different package identified with code number 03-2794-0 and an unknown lot number.The complaint product sample was disinfected.As the product complaint sample was being disinfected and prepared for analysis, a leak was found due to a fracture in the twister assembled to the main venous line.This fracture was found during the handling of the sample when performing the disinfection.The complaint sample was visually inspected.During the inspection under a microscope it was found that the venous twister port was broken during the handling when performing the disinfection.After further inspection, no other problems were found.A manufacturing review was performed on the products shipped to the customer for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.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.Upon completion of the evaluation, the reported event was confirmed.
Event or Problem Description
A user facility¿s clinic manager (cm) reported that a fresenius bloodline leaked fifteen minutes into a patient¿s hemodialysis (hd) treatment.The leak was due to faulty twist lines that had not yet been switched for access testing.The machine, a fresenius 2008t machine, did not alarm, but was not expected to.A fresenius dialyzer was also in use.There were no loose connections, changes in pressure and no damage was seen on the bloodline.The patient¿s estimated blood loss (ebl) was approximately 50ml.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: COMBISET ACCESS FLOW REVERSE CON TWISTER
• Common Device Name: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• 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: 22141428
• Report Number: 0008030665-2025-01261
• Device Sequence Number: 20870376
• Product Code: KOC
• UDI-Device Identifier: 00840861100316
• UDI-Public: 00840861100316
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K022536
• 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): 10/29/2025

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: 03-2794-0
• Device Lot Number: UNKNOWN
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 66 KG