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

Catalog Number	03-2622-3
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: b5.
Event or Problem Description
A user facility¿s senior clinical risk advisor reported to fresenius medical care canada (fmcc) that a fresenius combiset bloodline clotted eleven minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t machine, alarmed appropriately with an air detector alarm.The patient¿s estimated blood loss (ebl) is unknown.There was no patient serious injury or medical intervention required as a result of this event.It is unknown if the complaint device is available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.
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 senior clinical risk advisor reported to fresenius medical care canada (fmcc) that a fresenius combiset bloodline clotted eleven minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t machine, alarmed appropriately with an air detector alarm.The patient¿s estimated blood loss (ebl) is unknown.It was reported at intake that there was patient injury or illness, but what kind was not specified.The complaint device was reported to be available to be returned to the manufacturer for evaluation.
Event or Problem Description
A user facility¿s senior clinical risk advisor reported to fresenius medical care canada (fmcc) that a fresenius combiset bloodline clotted eleven minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The machine, a fresenius 2008t machine, alarmed appropriately with an air detector alarm.The patient¿s estimated blood loss (ebl) is unknown.There was no patient serious injury or medical intervention required as a result of this event.It is unknown if the complaint device is available to be returned to the manufacturer for evaluation.Multiple attempts have been made to contact the customer to obtain additional information related to the reported event.At this time, no additional information has been provided.
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: 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: 22677816
• Report Number: 0008030665-2025-01730
• Device Sequence Number: 9000013
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2025

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: 03-2622-3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2025
• Supplement Date Received by Manufacturer: 08/04/2025; 09/10/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/04/2025; 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.; FRESENIUS HEMODIALYSIS MACHINE.
• Patient Sex: Unknown