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

Model Number 5140-6221

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

Patient Problems Hypoxia (1918); Brain Injury (2219); Low Oxygen Saturation (2477)

Event Date 08/28/2015

Event Type  Death  

Manufacturer Narrative

Once the problem was recognized, the pump was clamped off and the patient was transitioned to va ecmo with existing cannulas and a separate ecmo circuit.The patient reportedly suffered from anoxic brain injury and expired 4 days later.The pump and cannulas were not returned for evaluation.The controller was returned for evaluation.Both the data logs and controller evaluation confirm that the system operated as intended.

Event Description

The (b)(6) female patient had been supported on tandemheart with transseptal cannulation for 8 days when she was transported to the operating room for placement of a durable ventricular assist device.Prior to transporting the patient to the operating room, the patient's hemodynamics and oxygenation were reportedly stable.At some point, most likely during the transport, the cannula migrated across the atrial septum into the right atrium.The anesthesia team intubated the patient in preparation for the surgical procedure and a short time later noticed a significant change in the patient's ability to adequately oxygenate.Therefore, their immediate actions focused on the intubation intervention they had just performed as the likely source of the oxygenation problem.Approximately 25 minutes elapsed before the problem was identified and the pump circuit was clamped.Echocardiographic imaging confirmed that the cannula had migrated from the left atrium to the right atrium.

• Brand Name: TANDEMHEART TRANSSEPTAL CANNULA - EF
• Type of Device: CANNULA, VASCULAR, 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: 5107962
• MDR Text Key: 26885652
• Report Number: 2531527-2015-00005
• 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
• Report Date: 09/28/2015

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: Health Professional
• 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: Not provided
• Initial Date FDA Received: 09/28/2015
• 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: 52 YR