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

Model Number 106531INT

Device Problems Mechanical Problem (1384); Misconnection (1399)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the system controller did not recognize the power connection on the black power lead.A power cable disconnect alarm on the black lead of the controller was noted.It was noted that the silicone isolation on the black lead was strongly twisted and that the kink protection cap got loose.The patient underwent controller exchange.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported damage to the black power cable of the system controller was confirmed via visual analysis.The heartmate 3 system controller (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review spanning approximately 9 days ( (b)(6) 2021 per timestamp).Beginning on (b)(6) 2021 at 07:55:43 - 8:58:33 there were multiple atypical power cable disconnects on the black power cable.During these events on (b)(6) 2021 at 08:09:59 - 08:10:18, 08:21:45 - 08:21:53, 08:25:01 - 08:25:03, when the white power cable was disconnected there were no external power alarms.These alarms would clear when the white power cable was reconnected to power.The backup battery provided power during these events.There were no other notable alarms in the log file.Pump operation was not affected.During product testing the system controller failed preliminary testing due to power cable disconnect alarms occurring on the black power cable.The power cables were tested, stripped, and it was observed that two wires on the black power cable were broken.The power cables on the controller were swapped with a working pair and the controller was able to pass functional and burn in testing with no issues.The observed alarms in the log file were determined to be due to the damage to the black power cable.The root cause of the reported damage to the black power cable was unable to be determined in this analysis.The device history records were reviewed and the records revealed the heartmate iii system controller (serial#: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.Heartmate iii instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 ¿ ¿alarms and troubleshooting¿ explains how to properly interpret and troubleshoot all alarms, including power cable disconnect and no external power alarms.Heartmate iii instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate iii patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment and contains a subsection ¿what not to do: driveline and cables¿.This section informs the user to check the system controller power cables and driveline for twisting, kinking, or bending which could cause damage to the wires inside.This section informs the user not to twist, kink, or sharply bend the system controller power cables and driveline cable and states ¿if the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten¿.The patient handbook cautions the 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.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: 12811018
• MDR Text Key: 285248153
• Report Number: 2916596-2021-06336
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/02/2022

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: 05/15/2024
• Device Model Number: 106531INT
• Device Lot Number: 8030004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/15/2021
• Supplement Dates Manufacturer Received: 01/31/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2021
• 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 Sex: Male