MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

Event Description

It was reported that the event and periodic logs contained controller clock corrupt and clock invalid events throughout the logs and was recommended to resync the controller clock to the system monitor.The log also contained intermittent low flow alarms with high pulsatility index (pi) events.On 24jun2022, additional information was received that the clock was successfully reset and the low flows are common for the patient as they are usually hypovolemic as they refuse to drink water.The low flow limit was also adjusted to 2liters per minute (lpm) in order to decrease the amount of alarms.The patient was to get an implantable cardioverter defibrillator (icd) interrogation for further work up as their blood pressure was low.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 lvas ifu is currently available.This ifu lists stroke as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu also provides information regarding anticoagulation, including the recommended inr (international normalized ratio) values.Section 2 "system operations" (under "system controller warnings and cautions") states, "check the system controller driveline connector to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump stops.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation." section 2 also contains a section titled "connecting the driveline to the system controller", which provides instructions on connecting/disconnecting the driveline to/from the system controller and making sure that it is fully and properly inserted into the system controller socket.Section 7 "alarms and troubleshooting" outlines all system controller alarms, including driveline disconnected alarms, as well as how to respond to each alarm condition.The system monitor section describes the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and explains that changes in patient conditions can result in low flow, such as hypertension.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm.The heartmate 3 lvas patient handbook is also currently available.This handbook warns in several sections: "check the system controller driveline connector often to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump will stop." and "the pump will stop if the driveline is disconnected from the system controller.If the driveline disconnects from the system controller, reconnect it right away to restart the pump.The pump cannot run without power." section 3 "powering the system" outlines the proper method for changing from the power module or mobile power unit to batteries and vice-versa under the sub-section titled ¿switching power sources¿.In addition, the patient handbook states, "call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment." the patient handbook also contains a section on handling emergencies.Section 5 ¿alarms and troubleshooting¿ contains information regarding all system controller alarms, including the driveline disconnected hazard alarm, and the proper actions associated with them.Evaluation of the submitted log files confirmed the clock set to the default time stamp indicating a system stop due to a complete loss of power had occurred; however, a direct cause for the reported event could not be conclusively determined through this evaluation.Additionally, evaluation of the submitted log files confirmed low flow alarms; however, a direct cause for the alarms could not be conclusively determined through this evaluation.The controller event log file contained approximately 2 days of data with the clock not set to the appropriate date.The date was recorded as 28 may 2000 indicating that a complete loss of external power event occurred at some point earlier; however, the event was not recorded within the log file.The date was set correctly to 24 june 2022 at the end of the log file.The log file recorded 8 low flow alarms throughout the log file when the flow dropped below the low flow threshold, that was previously lowered to 2.0 lpm, for 10 seconds or longer.The log files appeared to capture the pump operating as intended.The account reported that the patient had a corrupted clock and low flow alarms.The patient reportedly experiences frequent low flow alarms as they are usually hypovolemic with low water intake.The clock was able to be reset to the appropriate date, consistent with the submitted log files.Multiple requests for additional information were issued to the customer; however, no further information was provided.The patient remains ongoing on ventricular assist device (vad) support with no further related issues reported at this time.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 15043007
• MDR Text Key: 304024766
• Report Number: 2916596-2022-12330
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/24/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6625636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• 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 Sex: Female