MAUDE Adverse Event Report: ANGIODYNAMICS DURAFLOW HEMODIALYSIS CATHETER

Device Problems Failure To Adhere Or Bond (1031); Disconnection (1171); No Fail-Safe Mechanism (2990)

Patient Problems Cardiac Arrest (1762); Exsanguination (1841); Blood Loss (2597)

Event Date 08/09/2019

Event Type  Death  

Event Description

Pt attended regularly scheduled dialysis treatment.Pre-treatment vital signs were: weight 64.8 kg, blood pressure 148/57, pulse 72, respirations 18, temperature 96.8.Treatment started at 0623 via right internal jugular catheter at an ordered blood flow rate of 400 ml/min.Hemaclip was attached to venous line.At approx 0718, staff member noted blood on floor, treatment chair and pt's shirt.Staff reported the blue hub of the catheter had disconnected from the lumen of the catheter.Hemasafe clip remained attached to the bloodline.Pt non-responsive.Saline bolus given through red hub of catheter.Cpr started and 911 called.Per staff reports, as ems transferred the pt from the treatment chair to the stretcher, the red hub also detached from the catheter lumen.No add'l hospital.Pt expired in the emergency dept at 0815.

• Brand Name: DURAFLOW HEMODIALYSIS CATHETER
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS ; glens falls NY
• MDR Report Key: 8932054
• MDR Text Key: 155648021
• Report Number: 8932054
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2019
• Distributor Facility Aware Date: 08/09/2019
• Device Age: 5 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening
• Patient Age: 67 YR
• Patient Weight: 60