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

Model Number 106531

Device Problem Premature Discharge of Battery (1057)

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

Event Date 12/03/2021

Event Type  malfunction  

Event Description

It was reported that the patient complained that the battery gauge lights on the controller were running down to two bars within an hour or less of being on fully charged external batteries.The battery gauge on the batteries remained at 4-5 bars.The event log displayed multiple intermittent low flows where the low flow estimator dropped below 2.0 lpm (which is baseline for the patient) but did not display any alarms or unusual events in regards to battery use.The controller was tethered to the mobile power unit from (b)(6) 2021 7:22 pm to (b)(6) 2021 7:42 am.The patient did not experience any low voltage or low power alarms.The patient was switched to her backup controller and a replacement controller with low flow 2.0 software was requested.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the system controller¿s battery gauge not matching the battery lights on external 14-volt batteries was not confirmed.The provided log file and a log file extracted from the controller during testing were reviewed, collectively containing data spanning approximately 1 day (02dec2021 ¿ 03dec2021 per time stamp).The pump maintained speeds above the low speed limit while connected to the driveline, and no atypical events were observed.The returned system controller (serial number (b)(6)) was functionally tested and was found to perform as intended.The controller operated on charged 14-volt batteries for an extended period and its battery gauge was checked multiple times throughout testing.The controller¿s battery gauge always showed four full green bars while connected to the charged batteries, matching the batteries¿ gauges.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for the system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 patient handbook section 2 ¿how your heart pump works¿) instructs users on how to properly use the controller¿s battery gauge function.The battery power gauge shows the approximate charge status of the power source that is connected to the system controller¿s white and black power cables¿either the 14 volt lithium-ion batteries or the mobile power unit.The heartmate 3 patient handbook section titled "emergency contact list") 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 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) 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: 13125242
• MDR Text Key: 286274234
• Report Number: 2916596-2021-07364
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

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: 07/31/2020
• Device Model Number: 106531
• Device Catalogue Number: 106531US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/03/2021
• Initial Date FDA Received: 12/31/2021
• Supplement Dates Manufacturer Received: 02/11/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 61 KG