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	01/12/2024
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 the injection port on the saline line of the combiset bloodlines leaked during a patient's hemodialysis (hd) treatment resulting in air in the circuit.The patient's blood was not returned.Additional information was obtained during follow-up with the cm and a user facility registered nurse (rn).The reported issue was detected approximately 1h45 minutes after treatment initiation.The saline line was found to be dripping.The 2008t machine alarmed with an air detector message.The rn stated the entire circuit had filled with air.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was approximately 300 ml.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient completed treatment on the same machine with new supplies.The bloodline set 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 of the alleged malfunction was provided by the customer.In the photograph, it can be observed that the ¿y¿ injection site of the priming line is leaking.The reported issue is confirmed.The priming line used in the arterial line is a component that is manufactured by an external supplier; therefore, this kind of failure mode could only be caused by the external supplier.A notification was made to the external supplier about the alleged incident related to the injection site.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.
Event or Problem Description
A user facility clinic manager (cm) reported to fresenius that the injection port on the saline line of the combiset bloodlines leaked during a patient's hemodialysis (hd) treatment resulting in air in the circuit.The patient's blood was not returned.Additional information was obtained during follow-up with the cm and a user facility registered nurse (rn).The reported issue was detected approximately 1h45 minutes after treatment initiation.The saline line was found to be dripping.The 2008t machine alarmed with an air detector message.The rn stated the entire circuit had filled with air.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was approximately 300 ml.The patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient completed treatment on the same machine with new supplies.The bloodline set was discarded and is 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: 18527138
• Report Number: 0008030665-2024-00058
• Device Sequence Number: 6469492
• Product Code: FJK
• UDI-Device Identifier: 00840861100309
• UDI-Public: 00840861100309
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/23/2024

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 Catalogue Number: 03-2742-9
• Device Lot Number: 23NR01191
• 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: 01/12/2024
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Sex: Female