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	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility clinic manager (cm) reported to fresenius that towards the end of treatment the venous chamber of the combiset bloodline set 100% filled up and a certified clinical hemodialysis technician (ccht) noticed blood dripping from a small hole on the top part of the venous chamber.Additional information was obtained during follow-up.The reported issue occurred approximately an hour prior to treatment completion.The venous chamber filled with blood and a blood leak was visually observed that originated from a hole in the bloodline set.There was no serious injury or required medical intervention.The patient's estimated blood loss (ebl) is approximately 100 ml.Treatment was restarted and successfully completed on the same machine with new supplies.The sample was reported to be 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 clinic manager (cm) reported to fresenius that towards the end of treatment the venous chamber of the combiset bloodline set 100% filled up and a certified clinical hemodialysis technician (ccht) noticed blood dripping from a small hole on the top part of the venous chamber.Additional information was obtained during follow-up.The reported issue occurred approximately an hour prior to treatment completion.The venous chamber filled with blood and a blood leak was visually observed that originated from a hole in the bloodline set.There was no serious injury or required medical intervention.The patient's estimated blood loss (ebl) is approximately 100 ml.Treatment was restarted and successfully completed on the same machine with new supplies.The sample was reported to be available to be returned to the manufacturer for physical evaluation.
Additional Manufacturer Narrative
Additional information: d9, h3 plant investigation: the sample was returned to the manufacturer for physical evaluation.The sample is product 03-2742-9 and originated from lot 23hr01167.The sample was received open without its original packaging.As the complaint product sample was being disinfected and prepared for analysis, a leak was found on the venous chamber due a separation on the top cap.The complaint product sample was visually inspected and it was noted that the top of the venous chamber was not assembled properly, causing the separation.After further inspection, no other problems were found.The reported issue was confirmed.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.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: 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: 18384045
• Report Number: 0008030665-2023-01171
• Device Sequence Number: 2699425
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/09/2024

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: 06/30/2026
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 23HR01167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2023
• 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 DIALYZER; FRESENIUS DIALYZER; FRESENIUS HEMODIALYSIS (HD) MACHINE; FRESENIUS HEMODIALYSIS (HD) MACHINE
• Patient Sex: Male