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

Model Number 106531INT

Device Problem Material Deformation (2976)

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

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

Patient weight was estimated from most recent figure provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that there was damage to the outer shell of the controller's black connector cable and the outer shell of the ventricular assist device (vad) modular cable.The damage to both cables have been repaired with rescue tape.Controller and modular cable will be exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damage to the system controller¿s black power cable was confirmed via evaluation of the submitted photo, revealing a tear in the black cable¿s outer jacket which exposed the inner sheathing.The heartmate 3 system controller serial number: (b)(6) was not returned for further analysis.However, a log file containing approximately 21 days of data (14dec2021 ¿ 04jan2022 per timestamp) was submitted for review.The pump maintained a speed above the low speed limit throughout the log file, and there were no events observed that would indicate an issue with the operation of the controller.The root cause of the reported event was unable to conclusively determined via this analysis.Review of the device history record for the system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.The unit was shipped to the customer on 25apr2017.Heartmate 3 patient handbook section 5 "alarms and troubleshooting¿, addresses how to properly interpret and troubleshoot all system alarms including low voltage advisory alarms.Heartmate 3 patient handbook section 6 "equipment maintenance", describes how to care for and clean all equipment, including the system controller and its power cables.Heartmate 3 patient handbook section 10 entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the system controller power cables for damage.The patient handbook cautions the user 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

It was reported that the controller and modular cable were not exchanged and still used by the patient.The damage to the controller and modular cable's isolation sheath were superficial, and it was decided to just apply rescue tape.

• 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: 13203907
• MDR Text Key: 285634488
• Report Number: 2916596-2022-00065
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2020
• Device Model Number: 106531INT
• Device Lot Number: 5960081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2017
• 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 Sex: Male
• Patient Weight: 58 KG