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

Model Number SL-2000M2095D

Device Problems Obstruction of Flow (2423); Structural Problem (2506); Filtration Problem (2941)

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

Event Date 12/05/2022

Event Type  Injury  

Event Description

The tmp/venous monitoring pod on the venous line of the bbraun hemodialysis bloodlines (streamline airless system set) is not functioning properly and will not allow for blood to flow from the dialyzer back into the patient.The tmp pod has a flexible membrane inside it that due to the issue at hand, will not inflate/deflate/is not flexible to allow blood return to the patient and is resulting in clotted lines that have to be discarded and a new set up has to be prepared for the patient to be able to receive their hemodialysis treatment.

• Brand Name: STREAMLINE AIRLESS SYSTEM SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; bethlehem PA 18018 3524
• MDR Report Key: 15958946
• MDR Text Key: 305274507
• Report Number: MW5113719
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL-2000M2095D
• Device Lot Number: 20355002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American