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

Model Number 106531US

Device Problems Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 01/11/2022

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 had wear on both the white and black cables of the system controller.There was no pump dysfunction but the controller was replaced while in clinic.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of ¿wear noted to both white and black cables¿ was confirmed with the returned system controller (serial # (b)(6)).Visual inspection revealed several tears on the outer jacket of both power cables.The returned system controller was functionally tested using laboratory equipment and no functional issue was identified that could be correlated to the damage.The damaged section of the power cables was delayered for visual inspection.The underlying wires was uniformly spiraled with no visual damage.A root cause of the tears was not determined during the evaluation.Incidental finding: the observed green fluid substance is a fluid ingress issue and is an additional finding that did not result in any functional issue.The finding of the conductor breakdown is an additional finding that did not result in any functional issue.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.System controller (serial # (b)(6)) was shipped to the customer on 12dec2019.Heartmate 3 patient handbook rev c, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5 ¿alarms and troubleshooting¿ all alarm conditions are addressed.Also informs the user: ¿do not twist, kink, or sharply bend the driveline, system controller power cables, or mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible¿.Also, in this section, entitled ¿alarms and troubleshooting¿, all alarm conditions are addressed.Under section 6, entitled ¿caring for the equipment¿, addresses the cleaning and caring for the equipment that include cautions regarding submersion of the driveline, modular connector, system controller, or any external system components (such as the power module, the mobile power unit, batteries, power cables, or battery clips) into water or liquid.Submersion in water or liquid may cause the left ventricular assist device to stop.Heartmate 3 instructions for use rev c, ¿replace any equipment or system component that appears damaged or worn¿.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 SYSTEM CONTROLLER
• 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: 13252179
• MDR Text Key: 283825187
• Report Number: 2916596-2022-00232
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/07/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7287032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/08/2019
• 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: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American