MAUDE Adverse Event Report: CARDIACASSIST INC TANDEMHEART TRANSSEPTAL CANNULA; CATHETER, 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 03/19/2016

Event Type  Death  

Event Description

A (b)(6) year old female in cardiogenic shock was placed on support using a transseptal (ts) cannula.The day after initiation of support fluctuation in flows prompted bedside manipulation of the ts cannula in an attempt to move the tip of the cannula.As a result the ts cannula inadvertently relocated into the ra and the patient was taken to the ccl in order to place the ts cannula back into the la.The pump speed was reduced in the ccl to minimize the right to left shunt prior to replacement of the ts cannula and the patient arrested.A new ts cannula was placed and re-initiation of support was attempted, but flow was unable to be reestablished.

• Brand Name: TANDEMHEART TRANSSEPTAL CANNULA
• Type of Device: CATHETER, 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: 5552794
• MDR Text Key: 42027589
• Report Number: 2531527-2016-00006
• 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: 03/19/2016
• 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
• Patient Age: 70 YR