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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106762
Device Problems Electrical Power Problem (2925); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of below-average voltage values/low voltage alarms was confirmed via the provided log file; however, the reported ¿break in the white power cord¿ was not confirmed. The log file contained data spanning approximately 9 days (25may2022 ¿ 03jun2022 per timestamp). The pump maintained speeds above the low speed limit while connected to the driveline. The patient¿s voltage values were observed to be below average throughout the data while connected to batteries or to the mpu. Strings of low voltage advisory alarms were also intermittently observed while batteries were in use due to the rsoc within one cable fluctuating beneath the alarm threshold. The system controller (serial number (b)(4)) was not returned for analysis. The root causes of the reported events were unable to be conclusively determined through this analysis. Review of the device history record for system controller, serial number (b)(4), showed the device was manufactured in accordance with manufacturing and quality assurance specifications. The controller was shipped to the customer on 20apr2017. The heartmate ii patient handbook (rev. F, section 5 ¿alarms and troubleshooting¿) describes all alarms (visual and audible) and what action should be performed when they do occur, including alarms related to low voltage conditions. The heartmate ii patient handbook (rev. F, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including the system controller, and to obtain replacements if necessary. The heartmate ii patient handbook (rev. F, section titled ¿emergency contact list¿) cautions users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that the patient had been having low voltage advisory alarms since apr2022. Their batteries and battery clips were exchanged but the issue did not resolve. They had electrical tape applied to the white power cord of their controller. Log files confirmed times when the voltage supplied to the controller was lower than expected. This occurred while the patient was on wall power. The controller was exchanged and the alarms resolved. Related manufacturer report number: 2916596-2022-11604.
 
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Brand NameHEARTMATE II 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 Key14886471
MDR Text Key296859339
Report Number2916596-2022-11882
Device Sequence Number1
Product Code DSQ
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
Report Date 07/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2020
Device Model Number106762
Device Catalogue Number106762
Device Lot Number5954443
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/24/2017
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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