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

Model Number SL-2010M2096

Device Problem Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2022

Event Type  malfunction  

Event Description

Multiple micro bubbles noted in arterial pod and dialysis circuit.Initially, arterial pressure alarm went off followed by s.A.D.Alarm.Unable to clear micro bubbles, even with pod reset.Lot # matches additional lot #s recorded for dialysis streamline tubing issues.Lot # 00554003 removed from supply.

• Brand Name: STREAMLINE BLOODLINE SET FOR DIALOG+ HEMODIALYSIS SYSTEM
• 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: 15461626
• MDR Text Key: 300312341
• Report Number: 15461626
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367786
• UDI-Public: 04046964367786
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SL-2010M2096
• Device Catalogue Number: SL-2010M2096
• Device Lot Number: 00554003
• 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: 09/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1