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	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility's clinic manager (cm) reported that a fresenius bloodline had a crack in it during a patient's hemodialysis (hd) treatment.The machine, a fresenius 2008t machine, alarmed appropriately with an air detector alarm.A fresenius dialyzer was also in use.The leak was noted to originate at the twister line junction.The patient¿s estimated blood loss (ebl) was approximately 300 ml.There was no patient injury or medical intervention required as a result of this event.The patient was restarted on the same machine and treatment completed successfully with new supplies.No issues were noted during priming.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the complaint device was returned to the manufacturer for physical evaluation.As the complaint product sample was disinfected and prepared for analysis, a leak was found due to a separation in the arterial main line assembled to the twister.The complaint product sample was visually inspected and it was confirmed that the arterial twister port assembled to the arterial main line was broken.After further inspection, no other problems were found.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 clinic manager (cm) reported that a fresenius bloodline had a crack in it during a patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t machine, alarmed appropriately with an air detector alarm.A fresenius dialyzer was also in use.The leak was noted to originate at the twister line junction.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 was restarted on the same machine and treatment completed successfully with new supplies.No issues were noted during priming.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: 21733354
• Report Number: 0008030665-2025-00732
• Device Sequence Number: 11757580
• 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): 08/06/2025

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: 24SR01082
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 03/31/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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 DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.
• Patient Age: 79 YR
• Patient Sex: Unknown
• Patient Weight: 122 KG