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	03-2722-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility procurement specialist reported combiset hemodialysis (hd) bloodline that separated during treatment.Upon follow-up, the biomedical technician (bmt) stated immediately after initiation of the patient's treatment, a staff member noticed the saline line had separated along the tubing line that attached to the arterial chamber.The detachment at the t-junction caused saline to leak and for air to be introduced into the system.The patient¿s treatment was immediately halted and the patient¿s blood was not returned.The bmt stated the staff was able to prime the system without issue.The bmt stated that a fresenius 2008t machine and dialyzer were used for treatment and confirmed that there were no defects or damage seen on the machine, dialyzer or bloodlines prior to the event.The bmt stated blood loss was reported but the patient's estimated blood loss (ebl) was unknown.Immediately following the event, the patient was re-setup with new supplies on the same machine where the patient was able to complete treatment without further issue.The bmt confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The machine remains in service.The combi set was discarded and was no longer available to be returned for evaluation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Correction: g3 date received: 02/12/2026.
Event or Problem Description
A user facility procurement specialist reported combiset hemodialysis (hd) bloodline that separated during treatment.Upon follow-up, the biomedical technician (bmt) stated immediately after initiation of the patient's treatment, a staff member noticed the saline line had separated along the tubing line that attached to the arterial chamber.The detachment at the t-junction caused saline to leak and for air to be introduced into the system.The patient¿s treatment was immediately halted and the patient¿s blood was not returned.The bmt stated the staff was able to prime the system without issue.The bmt stated that a fresenius 2008t machine and dialyzer were used for treatment and confirmed that there were no defects or damage seen on the machine, dialyzer or bloodlines prior to the event.The bmt stated blood loss was reported but the patient's estimated blood loss (ebl) was unknown.Immediately following the event, the patient was re-setup with new supplies on the same machine where the patient was able to complete treatment without further issue.The bmt confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The machine remains in service.The combi set was discarded and was no longer available to be returned for evaluation.
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 procurement specialist reported combiset hemodialysis (hd) bloodline that separated during treatment.Upon follow-up, the biomedical technician (bmt) stated immediately after initiation of the patient's treatment, a staff member noticed the saline line had separated along the tubing line that attached to the arterial chamber.The detachment at the t-junction caused saline to leak and for air to be introduced into the system.The patient¿s treatment was immediately halted and the patient¿s blood was not returned.The bmt stated the staff was able to prime the system without issue.The bmt stated that a fresenius 2008t machine and dialyzer were used for treatment and confirmed that there were no defects or damage seen on the machine, dialyzer or bloodlines prior to the event.The bmt stated blood loss was reported but the patient's estimated blood loss (ebl) was unknown.Immediately following the event, the patient was re-setup with new supplies on the same machine where the patient was able to complete treatment without further issue.The bmt confirmed that there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The machine remains in service.The combi set was discarded and was no longer available to be returned for 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: 24368728
• Report Number: 0008030665-2026-00336
• Device Sequence Number: 9679222
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/23/2026

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: Other
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 25NR01277
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/09/2026; 04/23/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/09/2026; 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2025
• 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 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.; FRESENIUS DIALYZER.
• Patient Sex: Unknown