MAUDE Adverse Event Report: ORIGEN BIOMEDICAL, INC. ECMO DOUBLE LUMEN VV CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number VV28F

Device Problems Device Operates Differently Than Expected (2913); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 11/23/2016

Event Type  malfunction  

Event Description

Upon review of the extracorporeal membrane oxygenation (ecmo) cannulas, it was discovered by staff that these cannulas have a known problem with lack of barium impregnation, making the cannula not visible on x-ray.

• Brand Name: ECMO DOUBLE LUMEN VV CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ORIGEN BIOMEDICAL, INC.; 7000 burleson rd.; bldg d; austin TX 78744
• MDR Report Key: 6321596
• MDR Text Key: 67112330
• Report Number: 6321596
• 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: 01/30/2017,02/02/2017

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
• Device Expiration Date: 08/30/2018
• Device Model Number: VV28F
• Device Catalogue Number: VV28F
• Device Lot Number: N18487
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/10/2017
• 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