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 12/01/2023

Event Type  malfunction  

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 rn stated the reported issue occurred approximately 30-45 days prior to initial reporting.The rn stated that within the first hour of treatment that blood was visually observed dripping.The 2008t machine alarmed with an air detector message.The rn stated that air was sucked into the injection and backflowing out of saline line.The rn stated that the arterial side had filled with air.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was not provided.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

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 rn stated the reported issue occurred approximately 30-45 days prior to initial reporting.The rn stated that within the first hour of treatment that blood was visually observed dripping.The 2008t machine alarmed with an air detector message.The rn stated that air was sucked into the injection and backflowing out of saline line.The rn stated that the arterial side had filled with air.The patient¿s blood was not returned.The patient¿s estimated blood loss (ebl) was not provided.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: the sample was not returned to the manufacturer and the lot number was not provided.A manufacturing review was performed on the products shipped to the customer for the three (3) month time frame which immediately preceded the event occurrence date.This review included the lot numbers for all fresenius combiset bloodlines shipped to this account within the selected time frame.The entire set of lots have been sold and distributed.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.An investigation of the device history records (dhr) was conducted and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The product lots involved met all specifications for release.A review of the dhr did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

• 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: 18527497
• MDR Text Key: 333048056
• Report Number: 0008030665-2024-00059
• 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: 02/07/2024

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
• 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: 02/05/2024
• Supplement Dates FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: Male