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

Model Number 106524US

Device Problems Electro-Static Discharge (2149); Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 01/21/2022

Event Type  malfunction  

Event Description

The patient has a heartmate 3 lvad implanted about a year ago.The patient reported that on the third week of january patient's vad was alarming from the mobile power unit (mpu).Reported mpu no longer functioned.Denied symptoms during the event.Patient presented to clinic by the end of january with non-functioning mpu.Logfiles revealed electrostatic discharge event (esd), resulting in pump stop for an indeterminate amount of time (partial history overwritten).Pump had restarted with patient connecting to battery power.Additionally, logfiles show a second esd event on battery power.Primary controller and mpu replaced per abbott recommendation.Manufacturer response for lvad, heartmate 3 (per site reporter).No answer to date.

• Brand Name: HEARTMATE 3
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 13513713
• MDR Text Key: 285473599
• Report Number: 13513713
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/03/2022

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 Model Number: 106524US
• Device Catalogue Number: 106524US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2022
• Device Age: 1 YR
• Event Location: Home
• Date Report to Manufacturer: 02/11/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Race: Asian