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

Model Number SL-2010M2096

Device Problems Inflation Problem (1310); Leak/Splash (1354); Defective Device (2588); Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

6 equipment failure or malfunction incidents with the same lot number from feb to march 2022.Venous pod consistently filled with saline.Pod was unable to maintain any pressure to ensure pod was half filled with air.Defective lines were torn down, new lines were stung on same machine, with no issue.Saline line where you spike bag below that where the tubing connects together.They were leaking saline.Venous pod not able to maintain pressure-consistently filling with saline/blood.Small, gray foreign object in venous line, just below venous chamber.Dialysis tubing arterial pod defective, bulb kept sucking dry and alarming arterial pressure.Patient had to be rinsed back and new set up.The dialysis tubing has an arterial pod that would not stay inflated halfway through dialysis and required a full setup change to continue dialysis.This is the 4th tubing in the last several weeks to have a similar issue during dialysis.

• Brand Name: HEMODIALYSIS BLOODLINES 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 twelfth avenue; bethlehem PA 18018
• MDR Report Key: 14013628
• MDR Text Key: 288599847
• Report Number: 14013628
• 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: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• 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: 1154018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1