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

Model Number 106524US

Device Problems Contamination /Decontamination Problem (2895); Electrical Power Problem (2925)

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

Event Date 06/30/2022

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 during a pump preparation before an implant, the pump was placed in saline, connected to the controller, and the controller was connected to the patient cable with the white cable connected first.Once the cable was connected, the pump auto started pumping with no one pressing the pump start button on the clinical screen on the system monitor or any other button on the controller.There was no emergency backup battery (ebb) installed yet and the system monitor sowed the revolutions per minute (rpm) at 3000 an low speed limit of 5000.Mechanical circulatory systems (mcs) manager was consulted and it was decided to move forward with the implant.The pump worked as intended throughout the preparation and stopped when the pump stop command was pressed.Through this process, it was noted that the vad coordinator who was prepping the pump had a tear in their glove and was not sure of the items were touched.The pump was not implanted as it could have been contaminated.No log files were available as the only thing completed was the pump preparation and sterility was broken.All other equipment were back in circulation and no device was to be returned for evaluation.Related mfr: (b)(4).

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the pump and the reported breach in sterility due to a break in the ventricular assist device (vad) coordinator¿s glove could not be conclusively determined through this evaluation.The pump was not returned for evaluation.Review of the device history records, including the applicable sterility information, showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 5, "surgical procedures" (under ¿unpacking¿), notes to use care when unpacking items, as several must be placed in the sterile fields.This section also provides instructions on how to unpack all of the implant kit components in the operating room, including the pump and accessories tray.The user is also instructed to remove all the sterile components from the accessories tray and place in the sterile work area.In addition, section 5 (under ¿surgical considerations¿) warns that during the implant process, a complete backup system (implant kit and external components) must be available on-site and in close proximity for use in an emergency.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: 15076389
• MDR Text Key: 303060084
• Report Number: 2916596-2022-12353
• 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: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8470875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2022
• 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