MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Bacterial Infection (1735)

Event Date 05/10/2022

Event Type  Injury  

Event Description

It was reported that the patient was admitted on (b)(6) 2022 with fevers.The patient was found to have a pump pocket abscess.They underwent an incision and drainage on (b)(6) 2022.A wound vacuum assisted closure (vac) dressing was placed.Upon interrogation of the patient's controller, a low speed advisory alarm was noted from (b)(6) 2022.Higher flows and powers were seen as well.Log files confirmed a speed drop on (b)(6) 2022 that was caused by the pump stop button being activated at the system monitor.

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 2916596-2022-11094.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the submitted log file confirmed slight power and flow elevations; however, a specific cause as well as a direct correlation to the heartmate ii lvas, (b)(6), could not conclusively be determined through this evaluation.Evaluation of the submitted log file confirmed that throughout the log file, there were slight elevations in pump power and calculated flow.Pump power ranged from 5.5 watts to elevations as high as 8.2 watts, while pump flow ranged from 5.1 liters per minute (lpm) to elevations as high as 10.9 lpm.A specific cause for these changes in pump parameters could not be conclusively determined through this evaluation.The pump operated at or above the low speed limit until 08:03:45 on (b)(6) 2022 when a low speed hazard alarm was captured with a pump speed of 220 rpm due to the motor stop command being received from the system monitor.The pump regained speed on its own following this event and remained at or above the low speed limit for the remaining duration of the file.No other notable alarms were captured in this log file.The patient remains ongoing on the heartmate (hm) ii left ventricular assist system (lvas), (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.Review of the sterilization and packaging documentation showed no deviation from manufacturing specifications.The implant kit was shipped on (b)(6) 2021.The heartmate ii lvas ifu, rev.H and the heartmate ii patient handbook, rev.G are currently available.Pump speed, power, flow, and pi are addressed in section 1, ¿introduction¿, of this ifu.This section explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.This document also describes how pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Section 1 of this ifu lists infection (local, driveline or pump pocket infection) as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.Care instructions regarding infection are also provided in the ¿patient care and management¿ section of this ifu.Section 4 entitled ¿system monitor¿ explains how to use the pump stop button to turn off the pump.To use this feature, press and hold the pump stop button while the pump stop countdown counts down from 10 to 1, then a stopping pump message will be displayed.This section further states that the pump stops within the first few seconds of holding down the pump stop button.However, if the button is released before the countdown is complete, the pump resumes at the previously set mode and speed.Section 7 entitled "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 14568618
• MDR Text Key: 293150031
• Report Number: 2916596-2022-11093
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• 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,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/02/2022
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 7913012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 71 KG