MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. HEMODIALYSIS BLOODLINES; 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 07/22/2022

Event Type  malfunction  

Event Description

Health care provider had set up the machine and strung the lines.Once it was indicated to connect disposable to recirculation, health care provider connected the lines and went to release the air form the venous chamber but it would not release by opening the valve like it should.Health care provider tried to pull the air out with a syringe but once it was released it filled with air again.Health care provider tried to connect the couplings, while the blue was disconnected it filled with water but filled with air again as soon as the blue coupling was connected.All machine tests ran successfully but the chamber was still full of air.After discussing the problem with management we decided to take down the machine.The system passed all tests to start treatment but the chamber was still full of air.We pulled the lines and saved them to be checked for defects.Lot # a2200267.

• 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: 15327079
• MDR Text Key: 298970697
• Report Number: 15327079
• 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: 08/15/2022

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: A2200267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1