MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS

Model Number 106531US

Device Problem No Display/Image (1183)

Patient Problems Tachycardia (2095); Thrombus (2101)

Event Date 01/23/2020

Event Type  Injury  

Manufacturer Narrative

The details about pump stop, pump thrombus, tachycardia and pump exchange were captured under mfr# 2916596-2020-00431.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient's family reported that the controller started to alarm and then went "black." no lights were illuminated and none of the buttons worked.A controller exchange was performed by patient's family at home and the emergency medical services was called.Upon changing to the patient's backup controller, the controller went "black, no lights illuminated, and none of the buttons worked." the screen was completely black.Emergency medical services arrived on scene and verified that the pump was off.The patient was transported to emergency room with the controller attached to batteries.No further or additional information was provided.

Manufacturer Narrative

Section b5: the patient's original controller is addressed in mfr # 2916596-2020-00432.Section g3: correction.Section d4, h3, h4: additional information.Manufacturer's investigation conclusion: incidental findings: the leds that signify whether the pump is running were observed to be dim.The reported event of the system controller unexpectedly shutting down was not confirmed.Three log files were reviewed; however, they did not contain information related to the reported system controller behavior, as the driveline was not observed to be connected to the controller throughout the data.The returned system controller (serial number (b)(6)) was functionally tested and was found to perform as intended.No atypical events occurred throughout all testing, and the controller operated the mock loop as intended.The root cause of the reported event was unable to be determined through this analysis.The heartmate 3 patient handbook instructs users on how to properly use their system controller.Section 2, ¿how your heart pump works,¿ also instructs users on how to properly exchange the system controller.Do not attempt to exchange the system controller without having a trained, competent caregiver to assist.The heartmate 3 patient handbook cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9699898
• MDR Text Key: 179427297
• Report Number: 2916596-2020-00433
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 72