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

Model Number 106531US

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that when the patient came in for a routine ramp echocardiogram study, interrogation of the log files contained invalid clock faults that occurred "a few months ago." the patient did not report any total loss of power and had a history of unplugging their driveline from the system controller, "just to see what would happen." related pump mfr #: (b)(4).

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a clock not set alarm was confirmed via analysis of the submitted log files.The submitted controller event log file contained approximately 1 hour of data (19:32:23 ¿ 20:42:50 on 23mar2000 and 13:57:00 on 28jun2022 per the timestamps).The clock was initially set to 23mar2000 but was changed to 28jun2022 at the timestamp of 20:42:50 on 23mar2000.A clock not set alarm was active while the clock was set to 23mar2000, as expected.No other notable alarms were active in the log file.The pump maintained a speed above the low speed limit throughout the log file.The submitted controller periodic log file contained approximately 10.5 days of data (13mar2000 ¿ 23mar2000 per the timestamp).A clock not set alarm was active throughout the log file due to the controller clock being set to the year 2000.No other notable alarms were active in the log file.The pump maintained a speed above the low speed limit throughout the log file.The clock being set to march of 2000 indicates that the clock had previously been reset to the default timestamp of 01jan2000; a reset to the default timestamp is consistent with a total loss of power to the system, however, this was not captured in the log files as the clock reset was overwritten by newer data.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The system controller, serial number hsc-102797, was shipped to the customer on 13jul2021.Heartmate 3 patient handbook (rev.D), under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) (rev.C), under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the low voltage advisory/hazard, no external power, power cable disconnect, and driveline disconnected alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook (rev.D) and heartmate 3 ifu (rev.C) section 3 ¿powering the system¿ describes the various ways to the power the system, including how to use the 14v batteries, power module, mobile power unit, and universal batter charger, and how to switch between power sources.This section explains how to properly switch between power sources and states that at least one system controller power cable must be connected to a power source (mpu, power module, or two heartmate 14 volt lithium-ion batteries) at all times.This section also explains how to check the charge level of a 14v battery, and informs the user to ensure that the 14v battery is charged before use.This section also informs the user not to use batteries to power the system when sleeping, and to always connect to the power module or mpu when sleeping or when there is a chance of sleeping because a sleeping patient may not hear the system controller alarms.Heartmate 3 patient handbook (rev.D) section 2 "how your heart pump works" and heartmate 3 ifu (rev.C) section 2 "system operations" state that the backup battery is intended only for backup power during a power emergency.These sections also inform the user to check the system controller driveline connector to confirm that the driveline is securely inserted into the socket.The user is informed that if the driveline disconnects from the system controller, the pump will stop and to promptly reconnect the driveline to resume pump operation.Heartmate 3 ifu (rev.C) section 4 "system monitor" explains how to set the system controller clock using the system monitor.Heartmate 3 patient handbook (rev.D) 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.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (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 Key: 15074023
• MDR Text Key: 303061070
• Report Number: 2916596-2022-12095
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/11/2024
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8003435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White