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

Model Number VV13F

Device Problem Defective Device (2588)

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

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

Upon receipt, the catheter was immediately disinfected and photographed for investigation.The catheter was received as shown, with the tip cut off; the rest of the catheter was not returned.A small circuit was created by inserting the catheter tip into a container of water and connecting tubes to the barbs.A vacuum was pulled on the drainage line to pull the water through the venous lumen.The air leak could not be recreated with fluid in both lines of the circuit.It should be noted that the catheter was received and appeared to be smeared with an adhesive or sealant on the clear tubes.Since the lot number was not reported a specific batch record could not be investigated.Based on sales records, the last three lots of vv13f catheters shipped to nationwide (b)(6) hospital were all reviewed, no deviations were recorded on those lots.All catheters are inspected and undergo a pressure test prior to release, and all released catheters in these lots passed this pressure leak inspection.No similar complaints have been reported to origen on these lots or others.Based on this investigation, the cause for air in the circuit could not be determined.We will continue to pressure test all our catheters and monitor our complaints for any similar issues.

Event Description

Air was noted to be in the ecmo circuit x2 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.Device usage problem: device failed (e.G.Broke, couldn't get it to work or stopped working).

• Brand Name: ORIGEN REINFORCED DUAL LUMEN CATHETER
• Type of Device: VV ECMO CATHETER
• Manufacturer (Section D): ORIGEN BIOMEDICAL, INC; 7000 burleson rd.; bldg. d; austin TX 78744
• Manufacturer (Section G): ORIGEN BIOMEDICAL, INC; 7000 burleson rd.; bldg. d; austin TX 78744
• Manufacturer Contact: kiersten soderman ; 7000 burleson rd.; bldg. d; austin, TX 78744 ; 5126157606
• MDR Report Key: 8472114
• MDR Text Key: 146349793
• Report Number: 1646848-2019-00010
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2019

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 Model Number: VV13F
• Initial Date Manufacturer Received: 08/19/2016
• Initial Date FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 2 MO