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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Blood Protein Abnormal (4595)
Date of Event	01/11/2024
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 clinic manager (cm) reported to fresenius that a fluid leak occurred with the combiset bloodlines during a patient's hemodialysis (hd) treatment.The line that connects to the venous side of the fresenius dialyzer disengaged from the blue threaded connection.The issue occurred upon treatment initiation.Additional information was obtained during follow-up with the cm.There was no defect or damage noted to the bloodlines.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 a different machine with new supplies.The sample was reported to be available to be returned to the manufacturer for physical evaluation.
Event or Problem Description
A user facility clinic manager (cm) reported to fresenius that a fluid leak occurred with the combiset bloodlines during a patient's hemodialysis (hd) treatment.The line that connects to the venous side of the fresenius dialyzer disengaged from the blue threaded connection.The issue occurred upon treatment initiation.Additional information was obtained during follow-up with the cm.There was no defect or damage noted to the bloodlines.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 a different 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: plant investigation: the sample was returned to the manufacturer for physical evaluation.The sample originated from lot 23lr01191 from the product 03-2742-9.The sample was visually analyzed and the alleged problem was confirmed.A separation of the blue din connector to the venous main line was found.No solvent on the tube was observed.This kind of failure mode could be caused due to an incorrect solvent application on the component or due to a lack of solvent during the assembly of the components.A dimensional test was performed with the main venous line, the results were accepted.The blue din connector was not able to perform a dimensional test; the pin could not pass all the way through due to the blue din connector had small remaining parts of the tube.A device history record (dhr) review was performed for the involved lot of the product and there were no non-conformances, deviations or any associated rework related with the alleged failure mode during the assembly of the lot involved.All the applicable in-process and final inspection tests were found with acceptable results.
Event or Problem Description
A user facility clinic manager (cm) reported to fresenius that a fluid leak occurred with the combiset bloodlines during a patient's hemodialysis (hd) treatment.The line that connects to the venous side of the fresenius dialyzer disengaged from the blue threaded connection.The issue occurred upon treatment initiation.Additional information was obtained during follow-up with the cm.There was no defect or damage noted to the bloodlines.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 a different machine with new supplies.The sample was reported to be 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: 18519975
• Report Number: 0008030665-2024-00052
• Device Sequence Number: 6545400
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 02/28/2024

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: 09/30/2026
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 23LR01191
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 02/23/2024; 02/28/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 02/26/2024; 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 58 KG