MAUDE Adverse Event Report: TANDEM LIFE / LIVANOVA USA, INC. / CARDIAC ASSIST INC. TANDEM LIFE PROTEK LVAD; PVAD, CATHETER, CANNULA AND TUBING, VASCULAR CARDIOPULMONARY BYPASS

Model Number 00140398 TANDEM PUMP

Device Problems Device Alarm System (1012); Overheating of Device (1437); Insufficient Flow or Under Infusion (2182); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2018

Event Type  Injury  

Event Description

Per incident report: pt with temporary tandem heart protek left ventricular assist device placed (b)(6) 2018.Pt¿s tandem heart console began alarming ¿infusate press error¿, nurses assessed the infusate tubing and observed a kink in the tubing near the console.The tubing was taken out of the console and unkinked.Console then began alarming ¿low flow¿ and secondary motor control unit was initiated with screen showing ¿flow: 0.7 lpm and rpm: 6700¿.Primary nurse alerted charge nurse and resident.Charge nurse came to bedside and attempted to restart pump.Tandem heart screen showed ¿switchover¿ alert displaying ¿attention controller has switched to back up, ensure pump is connected to the controller and pump lower housing is de-aired and filled with saline¿.Charge nurse then checked lines and connections, where blood was backed up in the infusate line tubing near the console and pump was overheated to touch.No clot was found in the pump or tubing.Cardiothoracic surgery fellow, perfusionist and tandem heart rep were called.Pt had stable vital signs during low flows and was laying flat in case of air entering the system.Console was charged to back up and alarms continued.Perfusionist instructed charge nurse to not clamp the cannulas and continue flows until support staff arrived.Ct surgery fellow at bedside instructed nurse to prepare for pump exchange from tandem heart to centrimag.Tee done with anesthesia attending and pump exchanged without complication.

• Brand Name: TANDEM LIFE PROTEK LVAD
• Type of Device: PVAD, CATHETER, CANNULA AND TUBING, VASCULAR CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TANDEM LIFE / LIVANOVA USA, INC. / CARDIAC ASSIST INC.
• MDR Report Key: 8202768
• MDR Text Key: 132050077
• Report Number: MW5082649
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00140398 TANDEM PUMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 99