MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problems Decreased Pump Speed (1500); Electro-Static Discharge (2149); Insufficient Information (3190)

Patient Problem Dyspnea (1816)

Event Date 03/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented to clinic with left ventricular assist device (lvad) fault alarm.Speed was found to be set at 5000 with no set speed limit, but speed was previously set at 5200 when patient was last seen (b)(6) 2021.Attempts to reset the low speed limit were unsuccessful.Patient unsure when speed changed.Patient endorses increases shortness of breath (sob) with activity over the last 1-2 months.Driveline is visually intact, patient denies trauma, pulling, or other damage.Upon log file review, lvad internal faults were found.The faults appeared to be a result of electro-static discharge (esd) events on (b)(6) 2022.Lvad reset was recommended in order to resolve this alarm.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 21aug2020.Heartmate 3 instructions for use outlines all system alarms, including the lvad fault advisory, and the recommended actions associated with these events in the alarms and troubleshooting section.Section 6 of the hm3 ifu, "patient care and management" (under "postoperative patient care"), warns that static electricity can cause the lvad to stop and explains how it can be avoided.Section 6 (under "electrostatic discharge") explains that strong static discharges should be avoided.Additionally, the safety testing and classification tables in appendix c of this document include electrostatic discharge information.Section 7 "alarms and troubleshooting" describes all alarm conditions as well as the appropriate actions associated with them.Section 1 of the hm3 patient handbook, (under "general warnings"), warns the user: -do not touch television (tv) or computer screens while you have the pump.Tv and computer screens have strong static electricity.A strong electrical shock can damage electrical parts of the system and cause the pump to stop.-avoid activities and conditions that may induce strong static discharges (for example, touching a television or computer monitor screen) as electrostatic discharges may damage and/or interfere with the electrical parts of the system, and may cause the lvad to perform improperly or stop.Section 4 "living with the heartmate 3" contains a section on "static electricity", in which the user is warned to avoid activities that may cause static electricity and to discharge any built up esd by touching a metal surface before handling lvas components.Additionally, the testing & classification tables in section 9 of this document include electrostatic discharge.Heartmate 3 lvas patient handbook outlines all system alarms, including the lvad fault advisory, and the recommended actions associated with these events in the alarms and troubleshooting section.This handbook also warns the patient 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.The evaluation of the submitted log files confirmed four transient pump stops and associated lvad internal faults consistent with electrostatic discharge (esd) events.The controller event log file captured four pump stops on 13mar2022 at 05:23:41, 21:18:02, 21:18:41, and 22:53:46.During the events, the pump speed reduced to 0 rpm and the low current, com a, com b, power b broken, and pump stop faults were activated.These pump stops did not result in any alarms, and the pump appeared to ramp up to the set speed without issue following the event.Based on previous complaint history, this pump stop appears consistent with an esd event.Lvad internal faults were captured throughout the duration of the log file, which appeared to be the result of a previous esd event.The pump operated as intended at the set speed for the remainder of the log file following the esd event.The controller periodic also captured the lvad internal faults seen in the controller event log file.The account reported that the lvad internal faults resolved with a power cycle and controller change.The patient was discharged home and remains stable.The patient remains ongoing on vad support.No product available for investigation.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 14021882
• MDR Text Key: 288797606
• Report Number: 2916596-2022-10149
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• 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 Practitioner
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/06/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7603589
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2020
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White