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

Model Number 5140-6221

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 03/21/2016

Event Type  Death  

Event Description

A patient with large mi and cardiogenic shock was placed on transseptal (ts) support.During routine care the next day the cannula pulled back and a subsequent tee showed that the ts cannula was completely in ra.The staff reduced the flow and was in the process of taking the patient to the cath lab for repositioning or replacement of the cannula, but the patient arrested and expired before support could be reinstated.

• 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: 5552808
• MDR Text Key: 42027626
• Report Number: 2531527-2016-00007
• 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: 04/06/2016

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: 03/21/2016
• Initial Date FDA Received: 04/06/2016
• 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): Death