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

Model Number 106531INT

Device Problems Failure to Power Up (1476); Device Difficult to Setup or Prepare (1487)

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

Event Date 06/07/2022

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 the patient was admitted and was on dialysis; they were experiencing hypovolemia.The patient reportedly sat in a chair and suddenly became unconscious with associated low flow alarms.The patient's system controller was exchanged; the new system controller took several minutes to start the pump.The patient was moved to a bed; as the nurse lifted the patient's legs, their volume status improved and the pump started.Evaluation of the log files revealed the event was potentially caused by the percutaneous cable not being fully inserted into the second system controller.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the ¿low flow alarms, disconnection alarms of the perc lead and power cables¿ was confirmed via log file analysis.It was noted the log files were retrieved from two system controllers (serial # (b)(6)) and the events are interpreted in order of the time estimated between them.On june 7 from 10:45 am to 10:49 am, intermittent low flow alarm events were captured.The alarm was related to the flow estimation value being below the limit threshold (2.5 lpm).The pump speed value remained at 5,000 rpm during the low flow alarm events.It was noted the 14v battery/clip was disconnected from the black power cable at 10:48 am and then disconnected from the white power cable at 10:49 am.At 10:49 am, the driveline was physically disconnected with the associated active hazard alarms (lvad off, driveline disconnect, low flow).The driveline remained disconnected thereafter.The shutdown sequence was initiated at 11:14 am.(serial # (b)(6)).It was noted the system controller was exchanged with regards to the low flow alarm event at 10:45 am, which was suspected to be related to hypovolemia.It was noted the events below were estimated from the clock/time synced on february 4, 2000 at 23:53 pm.On 7jun2022 from 10:48 am, the 14v battery/clip was connected to the white power cable and shortly after another 14v battery/clip was connected to the black power cable.At 10:51 am, the driveline was connected the system controller and the system started operating at 4,700 rpm four seconds later.(serial # (b)(6)).The estimated time the pump was off was approximately two minutes.From the data, it appears the driveline was not fully connected.The time from the driveline connection to the system started operating is approximately four seconds, which is within the expected time.To date, the system controller (serial # (b)(6)) associated with the event was unavailable for an evaluation.The complaint file will close accordingly and will be reopened if pertinent information is received.Device history record indicated the device was manufactured in accordance to manufacturing (mfg) and quality assurance (qa) specifications.(b)(6) was shipped to the customer on 04may2022.Heartmate 3 patient handbook (rev.D) cautions the users to ¿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.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5 ¿alarms and troubleshooting¿ describes all alarms (visual and audible) and what action should be performed when they do occur.This includes driveline disconnected and low flow alarms.Driveline disconnected alarm 1.Immediately reconnect the driveline to the system controller and move the driveline safety lock on the system controller to the locked position.Also, check that the modular inline connector is secure.See page 2-23.2.If alarm persists after reconnecting the driveline, press any button on the system controller to attempt pump start.3.If the alarm still persists, check if the fixed speed setting is below 4000 rpm and the system controller¿s backup battery is not installed.Under these conditions, the pump can only be started from the system monitor¿s clinical or settings screen by pressing the pump start button.4.If driveline is connected and alarm persists, replace the system controller with a configured backup system controller.Low flow alarm indicating flow is less than 2.5 lpm.1.Ensure that the driveline is connected to system controller.2.Ensure that a power source is connected to system controller.3.Clinically evaluate patient.Under section 2, under ¿the system controller self test¿, the system controller self test is loud and bright.All of the lights, symbols, and sounds come on and ¿self test¿ appears on the screen.Also, in section 2, how your heart pump works, covers replacing the running system controller with a backup controller.Also, important warning information associated with the system controller exchange.Important! do not attempt to change your system controller without having a trained, competent caregiver at your side to assist.Follow all alarm instructions, including calling the hospital if instructed.Heartmate 3 instructions for use (rev.C) ¿replace any equipment or system component that appears damaged or worn¿.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: 14690143
• MDR Text Key: 297589227
• Report Number: 2916596-2022-11640
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• 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: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531INT
• Device Lot Number: 8330739
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2022
• 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