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	05/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility inventory manager reported a comibiset bloodline leak.Upon follow-up, the facility administrator (fa) reported a hemodialysis (hd) patient was 90 minutes into dialysis treatment on a fresenius 2008t machine when the machine prompted with an air leak detected message, and staff noticed blood dripping from the blood pump section of the dialysis tubing on the dialysis machine.Treatment was halted and the staff reported a 0.5cm visible crack in the line of the tubing.The fa confirmed that the machine was not affected or removed from service as the leak was observed from the tubing.No further damage and/or defects were noted.A fresenius 180nre dialyzer was used for treatment and the patient's blood was able to be returned.The fa stated that the patient¿s estimated blood loss (ebl) was minimal and less than 10cc.The fa confirmed there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment completed successfully with new tubing lines without further issue.Following treatment, the biomedical technician examined the machine blood pump rotor and no issues were noted.The complaint device was discarded and was no longer available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility inventory manager reported a comibiset bloodline leak.Upon follow-up, the facility administrator (fa) reported a hemodialysis (hd) patient was 90 minutes into dialysis treatment on a fresenius 2008t machine when the machine prompted with an air leak detected message, and staff noticed blood dripping from the blood pump section of the dialysis tubing on the dialysis machine.Treatment was halted and the staff reported a 0.5cm visible crack in the line of the tubing.The fa confirmed that the machine was not affected or removed from service as the leak was observed from the tubing.No further damage and/or defects were noted.A fresenius 180nre dialyzer was used for treatment and the patient's blood was able to be returned.The fa stated that the patient¿s estimated blood loss (ebl) was minimal and less than 10cc.The fa confirmed there was no patient injury, adverse events, or medical intervention required as a result of the reported event.The patient was restarted on the same machine and treatment completed successfully with new tubing lines without further issue.Following treatment, the biomedical technician examined the machine blood pump rotor and no issues were noted.The complaint device was discarded and was no longer available to be returned to the manufacturer 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.

• 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: 22127525
• Report Number: 0008030665-2025-01247
• Device Sequence Number: 8841624
• Product Code: FJK
• UDI-Device Identifier: 00840861100293
• UDI-Public: 00840861100293
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: Other
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 25DR01122
• 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: 05/23/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2025
• 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 BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 93 KG