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

Catalog Number SL-2000M2095

Device Problem Air/Gas in Device (4062)

Patient Problem Hemorrhage/Bleeding (1888)

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 connecting saline to arterial port for rinse back, tubing sucks air and patients blood is not returned or cleared from that portion of the tubing.She explained that when the treatment is finished and the staff tries to rinse back the patient blood and the pump is turning and attempting to return the blood, the saline line seems to be blocked and not allowing the saline to rinse back.The staff then hooks the patient up to the machine as they were during therapy and allows gravity to pull whatever blood is in the line back into the patient.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH A
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethelehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethelehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17870459
• MDR Text Key: 324926359
• Report Number: 2521402-2023-00234
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 04046964367762
• UDI-Public: (01)04046964367762
• 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: 10/04/2023

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-2000M2095
• Device Lot Number: A2300129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: No
• 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