MAUDE Adverse Event Report: HEMODIALYSIS LINES; CATHETER, HEMODIALYSIS, IMPLANTED

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/29/2023

Event Type  malfunction  

Event Description

There was a slice in the arterial side of the hemodialysis lines that was leaking blood.Patient was rinsed back his blood, and another tubing and dialyzer primed.Treatment was resumed.Doctor was notified, blood cultures and a one-time dose of vancomycin ordered for patient.Risk closure comments: tracking and trending.

• Brand Name: HEMODIALYSIS LINES
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• MDR Report Key: 17316726
• MDR Text Key: 319385168
• Report Number: 17316726
• Device Sequence Number: 1
• Product Code: MSD
• 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: 07/06/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1