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

Device Problem Fluid/Blood Leak (1250)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/12/2024

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 333045116
• Report Number: 0008030665-2024-00058
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/12/2024
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 02/22/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE.; FRESENIUS 2008T MACHINE.; FRESENIUS BLOODLINES.; FRESENIUS BLOODLINES.
• Patient Sex: Female