MAUDE Adverse Event Report: ORIGEN BIOMEDICAL ORIGEN ECMO 15 FR DUAL LUMEN CATHETER; ECMO 15 FR DUAL LUMEN CANNULA

Model Number 15 FR

Device Problem Kinked (1339)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 03/20/2016

Event Type  malfunction  

Event Description

Pt was placed on vv ecmo with a 15 fr dual lumen cannula.The pt slowly decompensated on (b)(6) 2016 and on (b)(6) 2016 the decision was made to change the 15 fr cannula to a different type of ecmo.At the time the cannula was removed it was noted to have a significant kink in the cannula, not able to be seen from outside the skin.This kink limited our flows and led to the compensation of the pt.Dates of use: (b)(6) 2016.

• Brand Name: ORIGEN ECMO 15 FR DUAL LUMEN CATHETER
• Type of Device: ECMO 15 FR DUAL LUMEN CANNULA
• Manufacturer (Section D): ORIGEN BIOMEDICAL ; austin TX
• MDR Report Key: 5551843
• MDR Text Key: 42036627
• Report Number: MW5061498
• Device Sequence Number: 1
• Product Code: DWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/24/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: 15 FR
• Device Lot Number: M17983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26 MO
• Patient Weight: 13