MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBISET SMARTECH BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2722-9C

Device Problem Fluid/Blood Leak (1250)

Patient Problem Anemia (1706)

Event Date 04/22/2022

Event Type  Injury  

Event Description

A user facility clinic manager (cm) reported that a blood leak occurred with the combiset smartech bloodlines approximately 30 minutes after the initiation of the patient¿s hemodialysis (hd) treatment.The cm stated during follow-up that air entered the lines through the arterial connection between the fistula needle and the bloodlines which resulted in blood clotting within the dialyzer.The cm also noted that the machine, a 2008t machine, alarmed with an air detection message.There was no defect, damage, or loose connections noted on the bloodlines.The cm stated there were no issues noticed during prime.The patient¿s estimated blood loss (ebl) was approximately 300 ml.The patient was moved to a different machine where they successfully completed treatment with new supplies.The patient¿s hemoglobin dropped (values not provided) after the leak event occurred.Although the patient is prescribed micera (dose and frequency unknown) for anemia, the patient required a blood transfusion the following week (date unknown) due to the low hemoglobin.The patient has fully recovered and continues to complete hd therapy as scheduled without issue.The complaint sample was reported to be available to be returned to the manufacturer for physical evaluation.

• Brand Name: COMBISET SMARTECH BLOODLINE
• 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
• MDR Report Key: 14374853
• MDR Text Key: 291501785
• Report Number: 3008730267-2022-00026
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201207
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 03-2722-9C
• Device Lot Number: 22BR01041
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/12/2022
• Distributor Facility Aware Date: 05/06/2022
• Device Age: MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/12/2022
• Date Manufacturer Received: 05/06/2022
• Date Device Manufactured: 02/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FRESENIUS 2008T MACHINE; FRESENIUS DIALYZER
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 96 KG