MAUDE Adverse Event Report: CARDIAC ASSIST, INC. LIFESPARC; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 5820-3118

Device Problem Migration (4003)

Patient Problems Pain (1994); Cardiac Perforation (2513); Cough (4457)

Event Date 11/30/2021

Event Type  Death  

Event Description

The pt was on a protek duo cannula and cardiohelp ecmo circuit.He was cannulated through the right internal jugular vein and the pump was draining from right atrium delivering post oxygenation to the pulmonary artery.During the pt's time on the pump, he was ambulatory to a chair and eating/speaking with staff.At the time of the event, he had not been up walking in 3-4 days because of his anxiety.He was having coughing spells and felt like he was short of breath.The day of the event he had done well with oxygenator exchange and was sitting up in bed showing the ecmo specialist pictures of his cats.He had a coughing spell and looked up at her as he yelled "ouch" and before he could even reach up, he slumped over in bed.Code was initiated per record.Prior to the event the pt had cannula re-sutured and secured at 1930 with an x-ray to follow (after any possible manipulation we verify positioning).Chest x-ray showed proper placement.The pt coded and we were unable to obtain return of spontaneous circulation autopsy revealed that the cannula migrated into the right ventricle causing a perforation.

• Brand Name: LIFESPARC
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIAC ASSIST, INC.; 620 alpha drive; pittsburgh PA 15238
• MDR Report Key: 13480062
• MDR Text Key: 285230353
• Report Number: 13480062
• 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
• Report Date: 12/16/2021,12/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 5820-3118
• Device Catalogue Number: 5820-3118
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/16/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 11680 DA
• Patient Sex: Male
• Patient Weight: 105 KG