MAUDE Adverse Event Report: ORIGEN BIOMEDICAL INC ORIGEN DUAL LUMEN CATHETER ECMO; CANNULA, CATHETER

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/13/2016

Event Type  malfunction  

Event Description

Air was noted to be in ecmo circuit x 2 during patient admit.It is unclear how the air was entering, there is concern that it is from the cannula even though there is no obvious defect.

• Brand Name: ORIGEN DUAL LUMEN CATHETER ECMO
• Type of Device: CANNULA, CATHETER
• Manufacturer (Section D): ORIGEN BIOMEDICAL INC; 7000 burleson rd bldg d; austin TX 78744
• MDR Report Key: 5839424
• MDR Text Key: 50914205
• Report Number: 5839424
• Device Sequence Number: 1
• Product Code: DWF
• 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: Other
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 07/20/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1