MAUDE Adverse Event Report: LIVANOVA 31 FRENCH PROTEKDUO VV CANNULAE; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 5140-5131

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2022

Event Type  malfunction  

Event Description

Patient was decannulated from vv ecmo.Upon inspection of the protekduo catheter damage was noted in two areas.

Event Description

Patient was decannulated from vv ecmo.Upon inspection of the protekduo catheter damage was noted in two areas.

• Brand Name: 31 FRENCH PROTEKDUO VV CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 13950739
• MDR Text Key: 288208199
• Report Number: 13950739
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

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 Model Number: 5140-5131
• Device Catalogue Number: 5140-5131
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/11/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 9125 DA
• Patient Sex: Male