MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number SL-2010M2096A

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2023

Event Type  malfunction  

Event Description

Shortly after beginning treatment, the registered nurse (rn) noticed a leak in the tubing.The leak was coming from a sealed coupling in the tubing near the blood pump.It was external to the machine.The nurse caught the issue right away and was able to stop the treatment.No harm reached the patient.If left undetected, air could have potentially been introduced to the tubing system through the leak.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 17939790
• MDR Text Key: 325737482
• Report Number: 17939790
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2010M2096A
• Device Catalogue Number: SL-2010M2096A
• Device Lot Number: 0061853878
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1