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

Catalog Number	03-2522-1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius that a combiset bloodline was found to have a tear in it while being used.Additional information was obtained through follow-up with the biomed and the facility administrator (fa) from the user facility.It was confirmed that a tear was found in the bloodline after blood was seen leaking from the blood pump area.It was unknown if there were any alarms from the 2008t machine.It was unknown how much blood loss there was.It was confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported events.The patient was set up with new supplies on the machine in use and they were able to complete treatment without further incident.When the bloodline was removed, a tear was identified on the blood pump segment of the combiset.No photos of the reported damage could be provided.The machine was removed from service and then evaluated by the biomed.The biomed said the blood pump rotor was found to be in good condition.They were unable to find any issues with the blood pump and no machine parts had to be replaced.The damaged bloodlines were not available to be sent back for evaluation as they were reportedly discarded.
Additional Manufacturer Narrative
Plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.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.The entire lot has been sold and distributed.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.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.
Event or Problem Description
A user facility biomedical technician (biomed) reported to fresenius that a combiset bloodline was found to have a tear in it while being used.Additional information was obtained through follow-up with the biomed and the facility administrator (fa) from the user facility.It was confirmed that a tear was found in the bloodline after blood was seen leaking from the blood pump area.It was unknown if there were any alarms from the 2008t machine.It was unknown how much blood loss there was.It was confirmed there was no patient serious injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported events.The patient was set up with new supplies on the machine in use and they were able to complete treatment without further incident.When the bloodline was removed, a tear was identified on the blood pump segment of the combiset.No photos of the reported damage could be provided.The machine was removed from service and then evaluated by the biomed.The biomed said the blood pump rotor was found to be in good condition.They were unable to find any issues with the blood pump and no machine parts had to be replaced.The damaged bloodlines were not available to be sent back for evaluation as they were reportedly discarded.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

• Brand Name: COMBISET BLOODLINE
• 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: 25262975
• Report Number: 0008030665-2026-00988
• Device Sequence Number: 9205374
• Product Code: FJK
• UDI-Device Identifier: 00840861102402
• UDI-Public: 00840861102402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2026

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: 03-2522-1
• Device Lot Number: 26AR01046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2026
• 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: FRESENIUS 2008T MACHINE.; FRESENIUS 2008T MACHINE.
• Patient Sex: Unknown