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

Model Number 106531US

Device Problem Material Deformation (2976)

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

Event Date 09/22/2021

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 on (b)(6) 2021 the patient had surgery related to a driveline infection.Following the procedure, the patient developed postoperative/post-anesthetic psychosis and began tugging at the system controller's power cables, eventually chewing on the connector on the white power cord.As a result, there was an interruption in the power supply from the power module as well as the 14v batteries.The controller was exchanged.Related mfr number: 2916596-2021-05630.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the system controller¿s white power cable being damaged, causing low voltage/power cable disconnect/no external alarms, was confirmed.The provided log file from the returned system controller contained data spanning approximately 5 days (b)(6) 2021 per time stamp).The pump maintained speeds above the low speed limit while connected to the driveline.Low voltage, power cable disconnect, and no external power alarms were all intermittently observed beginning on (b)(6) 2021 at 12:21, caused by the voltage fluctuating around the alarm thresholds.These alarms remained active until the controller was shut down sometime after 12:36 of the same day.The controller was observed to have been powered on again on (b)(6) 2021 in order to retrieve the log file.No other notable events were observed.The returned system controller (serial number (b)(6) was observed to have a damaged white power cable upon arrival.The inner wiring could be seen within the damage, and the green and gray inner wires (positive power lines) were also observed to be damaged.The controller was functionally tested and was found to alarm with low voltage/power cable disconnect/no external alarms upon manipulating its white power cable, as the observed damaged conductors were shorting to the cable¿s shielding.The controller¿s power cables were replaced with test cables, and the controller was functionally tested and was found to perform as intended when test cables were in use.The root cause of the damage to the white power cable was caused by the patient per the reported event.The heartmate 3 patient handbook instructs users to regularly inspect their equipment, including their system controllers, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.The heartmate 3 patient handbook cautions users 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.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.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: 12651802
• MDR Text Key: 277109833
• Report Number: 2916596-2021-05631
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• 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: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/30/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7601632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/18/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 11/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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 Sex: Male