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

Catalog Number SL-2000M2095

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Improper Flow or Infusion (2954)

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

Event Date 12/11/2023

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: brief inquiry description.Cuts in arterial pod end of blood pump segment.Detailed inquiry description.Right at the initiating of hd tx staff noticed that micro air bubbles on the top of dialyzer header and in venous chamber, upon inspection clinical practitioner found a few drops of blood at the blood pump roller track.Treatment was terminated.Upon inspection of the blood line, we found tiny pinched/cut like damage right above the arterial pod of the bloodline.Defected bloodline was rinsed with bleach and water.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).A device history record (dhr) review was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.One (1) photo was submitted to the manufacturer for evaluation.Through visual examination of the photo, it was observed that the tubing had a small cut.The sample within the photo is not with specification; the defect of tubing cut is confirmed.While the defect is confirmed, an exact root cause could not be determined.During the assembly/packaging process, some type of device, knife or razor that could generate a cut in the material is not handled, and the 100% leak test is carried out on the material during the manufacturing process.A test was carried out to verify the detection of leakage in the leak tester and the results show that the machine rejects the set if the product has a cut, leak in the pump segment or any other component.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH A
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018 0027
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18535891
• MDR Text Key: 333148276
• Report Number: 2521402-2024-00008
• 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,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• 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: A2300208
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• 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