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	03-2742-9
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
The clinic manager (cm) for a user facility reported to fresenius that a blood leak occurred with a custom combiset bloodline set upon initiating this patient¿s hemodialysis (hd) treatment.The bloodline set was tested and primed without issue.The patient was then connected for treatment to a fresenius 2008t machine with a fresenius dialyzer.The blood leak occurred as the blood flow rate (bfr) was increased.No machine alarms were received.The patient care technician (pct) had visually observed blood ¿shooting¿ from the arterial line.The cm indicated that holes were found in the tubing approximately 12 inches down from the catheter connection.Treatment was paused.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) for this treatment was 500 ml.There were no serious injuries or required medical intervention that resulted from these issues.Treatment was restarted and completed on a different machine with new supplies.The sample was discarded and are not available to be returned to the manufacturer for physical 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
The clinic manager (cm) for a user facility reported to fresenius that a blood leak occurred with a custom combiset bloodline set upon initiating this patient¿s hemodialysis (hd) treatment.The bloodline set was tested and primed without issue.The patient was then connected for treatment to a fresenius 2008t machine with a fresenius dialyzer.The blood leak occurred as the blood flow rate (bfr) was increased.No machine alarms were received.The patient care technician (pct) had visually observed blood ¿shooting¿ from the arterial line.The cm indicated that holes were found in the tubing approximately 12 inches down from the catheter connection.Treatment was paused.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) for this treatment was 500 ml.There were no serious injuries or required medical intervention that resulted from these issues.Treatment was restarted and completed on a different machine with new supplies.The sample was discarded and are not available to be returned to the manufacturer for physical 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: 21292645
• Report Number: 0008030665-2025-00271
• Device Sequence Number: 7775675
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2025

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: 03-2742-9
• Device Lot Number: 24PR01040
• 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: 01/31/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/20/2024
• 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 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 95 KG