MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. STREAMLESS AIRLINE SYSTEM FOR B BRAUN DIALOG MACHINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number SL2010M2096A

Device Problems Infusion or Flow Problem (2964); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

B.Braun streamless airline systems would not allow blood to be returned.Arterial line was disconnected from patient needle line and connected to port located above medication port and below the saline bag to allow blood to be returned.Port was faulty and would not allow saline to enter arterial line to reinfuse patient.

• Brand Name: STREAMLESS AIRLINE SYSTEM FOR B BRAUN DIALOG MACHINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16573734
• MDR Text Key: 311692316
• Report Number: MW5115827
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL2010M2096A
• Device Lot Number: 0061847729
• 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): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White