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

Model Number 106015

Device Problems Decreased Pump Speed (1500); Pumping Stopped (1503)

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

Event Date 10/04/2023

Event Type  malfunction  

Event Description

It was reported that while the patient was in the clinic for a routine log file check on (b)(6) 2023, a low speed advisory and pump off event appeared to have occurred a few weeks ago on (b)(6) 2023.This occurred once and the patient did not hear the alarm.The patient noted that the alarm occurred in the morning while tethered to the mobile power unit (mpu).There were no further alarms.It was noted that there were no obvious tears in the driveline.The patient was sent home.

Manufacturer Narrative

Section a4: patient weight is missing.Information was requested.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log file confirmed a transient pump stop; however, a specific cause for this event could not be conclusively determined through this evaluation.The submitted log file recorded a brief pump stop on (b)(6) 2023 while the patient was connected to the mobile power unit.The pump appeared to have operated as intended at the set speed prior to and following this event.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no further information was provided.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6).No further related events have been reported 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 heartmate ii left ventricular assist system (lvas) instructions for use (ifu is currently available.This ifu outlines the appropriate actions to perform in response to the pump stopping.The "alarms and troubleshooting" section outlines system controller alarms and how to respond to each alarm condition.The heartmate ii lvas patient handbook is also currently available.The ¿alarms and troubleshooting¿ section contains information regarding system controller alarms and the proper actions associated with them.This handbook contains important warnings related to pump stops.The patient handbook also cautions users 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.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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18181414
• MDR Text Key: 328630201
• Report Number: 2916596-2023-07885
• 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
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2017
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/21/2023
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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 Age: 80 YR
• Patient Sex: Male