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

Model Number 106531US

Device Problem Material Deformation (2976)

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

Event Date 03/27/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted to the emergency department (ed) on (b)(6)2022.Upon device interrogation and inspection the white power cord on the patient's primary pocket controller was found to be egregiously damaged making it unsafe to use.The patient reported that she doesn't know how the cord was damaged and that it "wasn't like that when she got here [ed]." the patient reported having to correct a female staff member in the ed around 18:30 on (b)(6) 2022 when she noticed the person attempting to pull the power cord off of the ed vad tower's power module (ac wall power unit) connection.The patient reported advising the staff member that she needed to twist the power cord off instead of pulling it.Injury to this piece of equipment was consistent with directly pulling the secured cord away from the twisted "nut" connection.The severe damage required significant effort/force and presented an immediate risk for malfunction, power supply interruption, and internal wire damage as the device no longer had a patent bend relief.The patient was switched to her backup pocket controller which she tolerated well with no ill effects.

Manufacturer Narrative

Section d6a: date of implant inadvertently reported in initial report and is not applicable for this device manufacturer's investigation conclusion: the reported event of a damaged strain relief on the heartmate 3 system controller (serial number: (b)(6)) was confirmed via visual analysis.A log file was downloaded from the returned heartmate 3 system controller and showed events spanning approximately 3 days (27mar2022 ¿ 28mar2022, 06may2022 per timestamp).Events occurring on (b)(6) 2022 were recorded during testing at abbott.There were no other notable alarms active in the log file that would indicate an issue with the system controller.The returned hm3 system controller was functionally tested and passed all tests.The controller was connected to a mock circulatory loop for an extended period of time without any issue.A root cause for the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed and the records revealed the heartmate 3 system controller (serial number: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment including the system controller power cables and power cable connectors.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate iii lvad, including inspecting the system controller power cables and power cable connectors for dirt, grease, or damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate iii patient handbook and heartmate iii instructions for use (ifu) caution 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

Related manufacturer reference number: 2916596-2022-11374.

• 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: 14252905
• MDR Text Key: 290457765
• Report Number: 2916596-2022-10702
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7719000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2020
• 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: 48 YR
• Patient Sex: Female
• Patient Weight: 63 KG