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

Model Number 106524US

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Nausea (1970); Diaphoresis (2452)

Event Date 07/09/2022

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 the patient was not feeling well with nausea and diaphoresis.Emergency medical services was called and it was noted that the flow was as low as 1.2 in the emergency room.The patient coded and was sent to the critical care unit.There were 2 or 3 no external power alarms.Log file analysis captured low flow events on (b)(6) 2022 at 0114-0203 with flow noted as low as 1.2 liters per minute.The flow recovered back to 4 liters per minute after this time.There were a couple of no external power events at (b)(6) 2022 at 0512 and 0514 as both power leads were disconnected which enabled the backup battery in the controller.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed low flow alarms; however, a specific cause for this finding could not be conclusively determined through this evaluation.A direct correlation between heartmate 3 left ventricular assist system (lvas), serial number: (b)(6), and the reported events could not be conclusively established through this evaluation.The submitted log files found that the pump operated at the set speed without issue.Low flow alarms were captured on (b)(6) 2022, one of which was sustained for approximately 20 minutes.Three no external power events were captured on (b)(6) 2022; refer to the controller investigation regarding this finding.The controller backup battery power the system until external power was restored.The system otherwise appeared to be operating as intended, and there were no other notable alarms active in the log files.Multiple requests for additional information regarding this event were submitted to the account; no response has been received at this time.The patient remains ongoing on (b)(6) with no further reported issues at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 02apr2021.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), is currently available.Section 1 ¿introduction¿ of this document lists adverse events that may be associated with the use of the heartmate 3 lvas.Section 1 also provides an explanation of all pump parameters, including flow.This section explains that pump flow is a calculated value that is estimated based on pump power.Section 4 ¿system monitor¿ provides information about the pump flow display and the low flow hazard alarm condition.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm (liters per minute) and explains that changes in patient conditions can result in low flow.Additionally, this section (under ¿optimal fixed speed¿) outlines how to determine the optimal fixed speed and low speed limit.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.The heartmate 3 lvas patient handbook is currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.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: 15114036
• MDR Text Key: 304597793
• Report Number: 2916596-2022-12259
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/19/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7845078
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 145 KG