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

Model Number 106531US

Device Problem Disconnection (1171)

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

Event Date 05/27/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a system stop was confirmed via the provided log file.The log file contained data spanning approximately 10 days (18may2022 ¿ 28may2022 per timestamp).The pump speed was observed to fall to 0 rpm on 27may2022 at 17:05:34; at this time, the driveline appeared to have been disconnected, as the pump¿s current was ~0 amps.The driveline appeared to have been reconnected at 17:05:40, and the pump resumed speeds above the low speed limit at 17:05:45.The system controller (serial number: (b)(4) was not returned for analysis.The root cause of the observed system stop appeared to have been user error in disconnecting the driveline, and no adverse patient consequences were reported as a result of the disconnection.Review of the device history record for system controller, serial number: (b)(4), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 patient handbook (rev.D, section 2 ¿how your heart pump works¿) instructs users to regularly ensure that their driveline is connected and secured within the system controller, and to reconnect it immediately in the case that it becomes disconnected.Users are warned that the pump will stop running when the driveline is disconnected.The heartmate 3 patient handbook (rev.D, section 5 ¿alarms and troubleshooting¿) instructs users on how to resolve alarms that sound from their system controller.The heartmate 3 patient handbook (rev.D, 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.

Event Description

It was reported that log file analysis found low flow, driveline disconnect, and lvad off alarms on 27may2022 where the driveline may have been momentarily disconnected from the controller.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• 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: 15129485
• MDR Text Key: 304008381
• Report Number: 2916596-2022-11439
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 8395629
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White