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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility medical director reported to fresenius that a leak occurred at the heparin line of the combiset bloodlines during the patient's hemodialysis (hd) treatment.The reported issue occurred within two minutes of treatment initiation on a fresenius 4008s machine.It was not reported that any defect or damage was noted to the bloodlines.The patient did not experience a serious injury or require medical intervention.The patient's estimated blood loss (ebl) was approximately 1 ml.Treatment was restarted on the same machine and successfully completed with new supplies.The sample is not available to be returned to the manufacturer for physical evaluation.
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 medical director reported to fresenius that a leak occurred at the heparin line of the combiset bloodlines during the patient's hemodialysis (hd) treatment.The reported issue occurred within two minutes of treatment initiation on a fresenius 4008s machine.It was not reported that any defect or damage was noted to the bloodlines.The patient did not experience a serious injury or require medical intervention.The patient's estimated blood loss (ebl) was approximately 1 ml.Treatment was restarted on the same machine and successfully completed with new supplies.The sample is 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.However, a photograph of the alleged malfunction was received from the customer.A separation on the arterial line from the assembly of the heparin line to red "t" connector was noted from the photograph.The alleged failure mode was confirmed; a separation was observed according with the photo received from the customer.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.

• 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: 18041228
• Report Number: 0008030665-2023-00991
• Device Sequence Number: 20700158
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 23DR01006
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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 4008S MACHINE; FRESENIUS 4008S MACHINE
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 72 KG