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

Model Number 106524US

Device Problem Electromagnetic Interference (1194)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts were made to obtain patient weight; however no additional information was provided.No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported the left ventricular device alarm (lvad) fault alarm appeared twice, briefly, during operation when the surgeon was using a bovie during chest closure.Log files were sent to technical services for review.The log files found two low flows on (b)(6) 2021 around 1:57 pm.The pump had a reduction in blood volume.Between 6:29pm and 6:30 pm, a few transient lvad_internal_fault & motor_instability events occurred.The pump did not stop during these events and it was suggested these events could be a result of electromagnetic fields from an electrostatic unit (esu).It did not appear these faults were a result of any device related issues.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the submitted log files confirmed transient left ventricular assist device (lvad) fault alarms and low flow alarms.Although a specific cause for these events could not be determined though this evaluation, the account communicated that the lvad fault alarms occurred in the operating room when the surgeon was using an electrosurgical tool.A direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not conclusively be established through this evaluation.The submitted controller event log file captured transient low flow alarms on (b)(6) 2021 at 13:57.Of note, pulsatility index (pi) was elevated during these alarms.In addition, the file captured transient lvad internal fault alarms on (b)(6) 2021 at 18:29:50 and 18:30:37.The alarms lasted for approximately 4 - 5 seconds each and were associated with a transient increase in pump power and rotor noise.Abbott technical services communicated that these events can be caused by electromagnetic fields from an electrosurgical unit.The system appeared to operate as intended at the set speed for the duration of the file.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), with no further related issues 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 3 lvas instructions for use (ifu), and the heartmate 3 lvas patient handbook, are currently available.Section 1 "introduction" provides an explanation of all pump parameters (including flow).Section 4 "system monitor" provides information about the pump flow display and explains that pump flow is estimated based on pump speed and the amount of power being provided to the pump motor.This section also provides information about the low flow hazard alarm condition and states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm.Changes in patient conditions can result in low flow.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Section 3, powering the system," warns that the heartmate power module (pm) and mobile power unit (mpu) radiate radio frequency energy.If not used according to instructions, the pm and mpu may cause harmful interference with nearby devices.Steps to confirm interference are provided.Section 5, "surgical procedures", warns that the use of electrocautery devices may temporarily interfere with heartmate 3 pump operation.When electrocautery has been discontinued, there is no interference with pump operation.The safety testing and classification section of the ifu states that if the hm3 lvas does cause interference to another device, the user is encouraged to try to correct the interference by reorienting or relocating the equipment, increase the separation between the equipment, connect the equipment to an outlet on a circuit different from that to which other devices are connected, or contact the manufacturer for assistance.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 (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: 12658882
• MDR Text Key: 277264145
• Report Number: 2916596-2021-05661
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8025894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2021
• 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: 54 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic