MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. STREAMLINE BLOODLINE SET FOR DIALOG DR; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number SL-2010M2096A

Device Problem Improper Flow or Infusion (2954)

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

Event Date 01/26/2022

Event Type  malfunction  

Event Description

Dialysis tubing had an issue with the venous pod.It was not functioning correctly after interventions and continued to give alarms stopping the machine.

• Brand Name: STREAMLINE BLOODLINE SET FOR DIALOG DR
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th ave; bethlehem PA 18018
• MDR Report Key: 13558699
• MDR Text Key: 285818013
• Report Number: 13558699
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• 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: 1274926
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 02/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1