MAUDE Adverse Event Report: ORIGEN BIOMEDICAL ORIGEN REINFORCED DURAL LUMEN ECMO CATHETER; ECMO WIRE-REINFORCED CATHETER

Model Number VV13F

Device Problems Failure To Adhere Or Bond (1031); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problems Hypoxia (1918); Neurological Deficit/Dysfunction (1982)

Event Date 03/25/2015

Event Type  Death  

Event Description

Pt on ecmo secondary to respiratory failure, but improving.Origen reinforced dual lumen ecmo catheter used as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein cam apart, causing extreme blood loss, extended period of oxygen deprivation and extended cardiopulmonary resuscitation.The pt was neurologically healthy prior to the event, but sustained a severe neurological injury as a result of the catheter failure.

• Brand Name: ORIGEN REINFORCED DURAL LUMEN ECMO CATHETER
• Type of Device: ECMO WIRE-REINFORCED CATHETER
• Manufacturer (Section D): ORIGEN BIOMEDICAL; austin TX
• MDR Report Key: 4690361
• MDR Text Key: 21081089
• Report Number: 4690361
• Device Sequence Number: 1
• Product Code: DWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: VV13F
• Device Lot Number: N18549
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/06/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2015
• Distributor Facility Aware Date: 03/25/2015
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECMO MACHINE
• Patient Outcome(s): Death
• Patient Age: 2 MO
• Patient Weight: 5