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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/11/2024

Event Type  Death  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Multiple attempts were made to contact the initial reporter and end customer for additional information.At this time, no additional information or sample were provided for evaluation.Based on the data reported, b.Braun is unable to determine the root cause of the reported incident.There is currently no indication that a malfunction occurred which caused or contributed to the incident.Out of an abundance of caution, this event is being reported as an adverse event.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.

Event Description

As reported by the user facility: "reported that the bloodline while being used on a patient became disconnected from the catheter and the person bled out; subsequently dying on site.The amount of blood loss is undetermined but they coded right afterwards.".The event occurred on 11jan2024 at (b)(6).Reporter was very reluctant to provide any additional information as she was afraid to overstep her role.At this time, no additional information has been provided despite attempts to contact the initial reporter and end customer.

• Brand Name: HEMODIALYSIS BLOODLINES
• Type of Device: SET, TUBING, BLOOD, WITH A
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 824 12th avenue; bethlehem PA 18018
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18651294
• MDR Text Key: 334663161
• Report Number: 2521402-2024-00030
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• 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
• Patient Outcome(s): Death