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

Model Number 106531US

Device Problems Display or Visual Feedback Problem (1184); Electrical Power Problem (2925); Environmental Compatibility Problem (2929); Output Problem (3005)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2020 the patient's controller started alarming with messages displaying "pump off" and "replace system controller." the patient switched their controller to the backup.There were no other alarms after the controller exchange.The log file appeared normal until (b)(6) 2020 at 15:06:05 when the rsoc voltage level on the white lead increased to 17.011 volts and decreased to 5.4 volts at 15:08:08.This occurred while the patient was connected to the power module.The voltage remained unstable for the remainder of the log file.On (b)(6) 2020 at 15:37:59 a controller internal fault event occurred due to an lcd communication issue.This was followed by a driveline disconnect on (b)(6) 2020 at 15:41:53 when the controller was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a controller fault alarm and atypical relative state of charge (rsoc) voltages on the white power cable was confirmed via analysis of the log files and reproduced during testing of the returned system controller (serial number: (b)(6)).The reported event of a "pump off" message was not confirmed.The submitted log file and the log file downloaded from the returned controller contained approximately 1.5 days of data combined ((b)(6)2020 - (b)(6)2020 and (b)(6) 2020 per the time stamp).The log file captured a drop in the relative state of charge (rsoc) voltage while connected to the power module on (b)(6)2020 at 15:08:08, resulting in a power cable disconnect alarm.The rsoc voltage on the white power cable fluctuated and did not return to its appropriate voltage range for the remainder of the log file, resulting in intermittent power cable disconnect and low voltage advisory alarms; the atypical alarms occurred while connected to the power module and while connected to a 14v battery.A controller fault alarm was captured on (b)(6)2020 from 15:37:27 to 15:37:41 due to an lcd communication fault.The alarm then reactivated on (b)(6)2020 at 15:37:59 and remained active for the remainder of the log file.The driveline was disconnected on (b)(6)2020 at 15:41:53 to exchange the system controller and the controller was powered off some time after 15:43:28.The controller was then briefly reconnected to the power module on (b)(6)2020, operating in charge mode; the atypical rsoc voltage on the white power cable and the controller fault alarm associated with the lcd communication fault were both observed at this time.No other notable alarms were active in the log files.The pump maintained a speed above the low speed limit while the driveline was connected.The returned system controller was connected to a test power module, system monitor, and mock circulatory loop, a replace system controller alarm associated with an lcd communication fault and a power cable disconnect alarm on the white power cable activated immediately, reproducing the reported event.The alarms did not affect the controller¿s ability to operate the pump at the set speed.The controller was disassembled for inspection of the internal components, revealing a white and green residue consistent with dried fluid on the main printed circuit board (pcb).The fluid ingress resulted in corrosion of several components, and multiple components were partially detached from their solder pads.The observed component damage would result in the reported controller fault alarms and atypical rsoc voltages on the white power cable.The main pcb was replaced and the controller was reconnected to a test power module, system monitor, and mock circulatory loop, and the controller functioned as intended without any issues or atypical alarms produced.The reported event was determined to be caused by component damage on the main pcb due to fluid ingress; however, the root cause of the fluid ingress could not be conclusively determined through this analysis.Heartmate 3 instructions for use section 7, entitled ¿alarms and troubleshooting¿, and heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿ covers all alarms (visual and audible), including the replace system controller, controller internal fault, low voltage advisory/hazard, pump off, backup battery fault, and power cable disconnect alarm conditions, and the actions to take if the alarm cannot be resolved.The section 5 subsection, entitled "what not to do: driveline and cables", advises to inspect the system controller power cables for twisting, kinking, or bending, which could cause damage to the inner wires.Heartmate 3 patient handbook section 4, entitled ¿living with the heartmate 3¿, explains that the system controller must be kept dry at all times and to never swim or take baths.Users are instructed not to shower without a doctor¿s approval, and to never shower with the shower bag.This section also states ¿although the external components of the heartmate 3 left ventricular assist system are moisture-resistant, they are not waterproof.Take care to protect system components from water or moisture, whether indoors showering or outdoors in a heavy rain.If the components have contact with water or moisture, you may receive an electrical shock or the pump may stop¿.Heartmate 3 patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the system controller and power cables.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the system controller and power cables.This section also informs the user to replace any equipment or system component that appears damaged or worn.The heartmate 3 patient handbook and the heartmate 3 instructions for use caution the user 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.The device history records were reviewed and the records revealed that the heartmate 3 system controller, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 system controller was shipped to the customer on (b)(6)2019.No further information was provided.The manufacturer is closing the file on this complaint.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11056940
• MDR Text Key: 223725336
• Report Number: 2916596-2020-06063
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/23/2021
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6710352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 75