MAUDE Adverse Event Report: B. BRAUN DOMINICIAN REPULIC INC. HEMODIALYSIS BLOODLINES; SET, TUBING, BLOOD, WITH A

Catalog Number SL-2010M2096A

Device Problem Air/Gas in Device (4062)

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

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: when staff approached the chairside, they noted air in the venous line past the air detector.Staff stopped the blood pump immediately and called more experienced staff to the chairside.Pt was placed in trendelenburg on her left side.Microbubbles were noted throughout the arterial line and in the arterial needle tubing.When staff attempted to aspirate the arterial needle, no flow was noted, likely representing a clot on the needle tip that had been producing air bubbles due to turbulence as blood pulled past the clot.Regardless of the source, air should not have been able to pass the air detector without stopping the machine.No injury reported.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH A
• Manufacturer (Section D): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18660142
• MDR Text Key: 334773024
• Report Number: 2523676-2024-00106
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080807
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/07/2024

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 Operator: Health Professional
• Device Catalogue Number: SL-2010M2096A
• Device Lot Number: 0061897512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1