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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106531INT
Device Problems No Display/Image (1183); Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2022
Event Type  malfunction  
Event Description
It was reported that the patient experienced an alarm from the system controller. The system controller screen was black and green pump icon was black indicating a pump stop. The patient was feeling well. The patient was on batteries when the event happened. The patient exchanged both 14v batteries and the alarm disappeared and the green pump icon was lit green again, indicating the pump was running. After exchanging the batteries, the system controller screen was no longer black. The ventricular assist device (vad) coordinator decided to exchange the system controller as they suspected the system controller was having issues and sent the patient home. Related manufacturer report number: 2916596-2022-11383.
 
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.  .
 
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Brand NameHEARTMATE 3 SYSTEM CONTROLLER
Type of DeviceVENTRICULAR (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
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key14568599
MDR Text Key294675143
Report Number2916596-2022-11384
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeDA
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106531INT
Device Lot Number7628396
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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