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	11/07/2023
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
A user facility medical director reported to fresenius that a blood leak occurred during a patient's hemodialysis (hd) treatment with the combiset bloodlines.The heparin line detached from the bloodline set.The bloodlines were replaced to resolve the reported issue and complete treatment.Additional information was obtained during follow-up.The reported issue occurred approximately an hour and a half into treatment.No alarms were received from the machine (model unknown).It was not stated whether there was a change or disruption in pressure that would have caused the reported issue or triggered the machine to alarm.The patient did not experience a serious injury or require medical intervention.The patient's estimated blood loss (ebl) is approximately 50 ml.The bloodlines were replaced and treatment was restarted and successfully completed on the same machine with the same dialyzer.The sample was discarded and is not available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
A user facility medical director reported to fresenius that a blood leak occurred during a patient's hemodialysis (hd) treatment with the combiset bloodlines.The heparin line detached from the bloodline set.The bloodlines were replaced to resolve the reported issue and complete treatment.Additional information was obtained during follow-up.The reported issue occurred approximately an hour and a half into treatment.No alarms were received from the machine (model unknown).It was not stated whether there was a change or disruption in pressure that would have caused the reported issue or triggered the machine to alarm.The patient did not experience a serious injury or require medical intervention.The patient's estimated blood loss (ebl) is approximately 50 ml.The bloodlines were replaced and treatment was restarted and successfully completed on the same machine with the same dialyzer.The sample was discarded and 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 was received from the customer and it was confirmed that the heparin line detached from the bloodline set.The reported event was confirmed in accordance with the picture received.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.

• 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: 18185551
• Report Number: 0008030665-2023-01067
• Device Sequence Number: 6646870
• 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
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 06/30/2026
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 23HR01055
• Was Device Available for Evaluation?: No
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 97 KG