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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 VENTRICULAR (ASSISST) BYPASS Back to Search Results
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.
 
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Brand NameHEARTMATE 3
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key13513713
MDR Text Key285473599
Report Number13513713
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number106524US
Device Catalogue Number106524US
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2022
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2022
Device Age1 YR
Event Location Home
Date Report to Manufacturer02/11/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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