MAUDE Adverse Event Report: CARDIACASSIST INC TANDEMHEART TRANSSEPTAL CANNULA; CANNULA, CARDIOPULMONARY BYPASS

Model Number 5140-6221

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/29/2016

Event Type  Injury  

Event Description

During the afternoon of (b)(6) 2016, a few changes were noted related to the patient on la/fa support.The patients map was noted to be lower than previously reported (exact numbers not available), the flow on the tandem controller was noted to be approximately 0.5 lpm less than previously noted at the same pump speed.The team performed a tee which reveled a large pericardial effusion.The tip of the ts cannula was noted to be so deep into the la appendage that it was actually slightly protruding through the wall of the laa.A bedside pericardiocentesis was performed and 300 ml of sanguineous fluid was removed.The patient was stabilized through this procedure and transferred to the or for further management.The surgical team transitioned the patient to surgical support with a different extracorporeal pump and central cannulation.The ts cannula was removed without further incident.The laa "sealed" on its own and did not require further surgical intervention.

• Brand Name: TANDEMHEART TRANSSEPTAL CANNULA
• Type of Device: CANNULA, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): CARDIACASSIST INC; 240 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC; 240 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: greg johnson ; 240 alpha drive; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 6234298
• MDR Text Key: 64213814
• Report Number: 2531527-2017-00001
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052570
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2017

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 Operator: Physician
• Device Model Number: 5140-6221
• Device Catalogue Number: 5140-6221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2017
• Initial Date FDA Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention
• Patient Age: 62 YR