MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; Ventricular (assist) bypass

Model Number 106524US

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related mfr #2916596-2024-01083.It was reported that during pump prep, prior to implantation, the heartmate 3 pump was confirmed to be off by the system monitor when the heartmate 3 pump was taken out of saline.Once on the table, there was a brief power spike of 20.1 watts after which it returned to a baseline of 0.9 watts.The device was on extended silence; however, there was still an audible alarm as though the power module had been unplugged from wall power.There was an intermittent beeping sound for a brief period while the power was elevated.The "css" team tested the heartmate 3 pump in saline two more times after the event, with no further complications.However, after talking to the abbott engineering team, the abbott engineering team and the clinical determined it would be safer for the patient if the device was not used.The "css" team opened the backup heartmate 3 pump with no further complications.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: Ventricular (assist) bypass
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18832832
• MDR Text Key: 336899375
• Report Number: 2916596-2024-01082
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 106524US
• Device Lot Number: 10135731
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/02/2024
• 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