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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106762
Device Problems Disconnection (1171); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/13/2021
Event Type  malfunction  
Manufacturer Narrative
Patient weight was requested, but not provided. Serial number of the system controller was requested, but not provided. 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 was admitted for covid. During ems transportation, the patient had a "connect power" alarm while tethered to batteries. The alarm resolved when they were connected to wall power. It was noted that the white power cable on the controller had an area of damage with a blue wire visible. The site planned to keep the patient on wall power overnight and monitor for further alarms. The patient's international normalized ratio (inr) was sub-therapeutic; the site preferred not to exchange the controller.
 
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Brand NameHEARTMATE II SYSTEM CONTROLLER
Type of DeviceVENTRICULAR (ASSISST) 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 Key13192061
MDR Text Key284017503
Report Number2916596-2021-07555
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011286
UDI-Public813024011286
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106762
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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