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

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/31/2023

Event Type  malfunction  

Event Description

A hole in the arterial side of the hemodialysis lines caused a leak.Treatment stopped, patient did not get his blood returned to him.New tubing and dialyzer primed, and treatment resumed.Doctor notified, blood cultures and one time dose of vancomycin ordered.Risk closure comments: tracking and trending.

• Brand Name: HEMODIALYSIS LINES
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• MDR Report Key: 17320042
• MDR Text Key: 319377653
• Report Number: 17320042
• 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

• Date FDA Received: 07/13/2023
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1