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

Model Number 106531US

Device Problems Disconnection (1171); Failure to Interrogate (1332); Detachment of Device or Device Component (2907); Electrical Power Problem (2925); Material Deformation (2976)

Patient Problems Dizziness (2194); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2021

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 patient presented to ventricular assist device clinic with complaints of alarms going off for a week.The patient said they have been silencing their lvad alarms for the last week.They stated that they felt a bit lightheaded and dizzy.The patient had a mean arterial pressure (map) of 67mmhg, a pulse oximetry of 97%.The patient was warm to the touch.Upon interrogation of their controller, the customer found the patient's pump speed to be 5200rpm with a pulsatility index of 3.8, pump power was 3.8 w, and the flow was 3.5lpm.They also discovered active power cable disconnect alarms on alternating black and white leads.There was a low voltage hazard with a red led.There were no green circle of life lights on the controller.There was physical damage noted to each power cable bend relief to the point of broken bend reliefs.There was no exposed wires on the power cables or driveline.The controller was swapped out for the patient's back-up controller.All alarms ceased and green controller arrows are present.The account was not sure if the patient's device was having any pump stops as the controller would not sync to the system monitor or to the heartmate touch.The patient reported feeling alleviated with a lessening of symptoms while on the new controller.At present, the patient has remained stable and has been supported without active alarms on their back-up controller.A review of the log files revealed no unusual events seen within the log files.

Manufacturer Narrative

Main investigation conclusion the reported event of power cable disconnect alarms was able to be confirmed.The heartmate 3 system controller (serial number: (b)(6)) was returned for analysis and a log file was downloaded for review.A review of the submitted log files showed events spanning approximately 3 days ((b)(6) 2021, (b)(6) 2021, (b)(6) 2000 per timestamp).Events captured on (b)(6) 2021 and (b)(6) 2000 took place in the testing labs at abbott.Events recorded on (b)(6) 2000 were captured while the clock was not set; therefore, the exact date and times of the events were unable to be accurately recorded.Atypical power cable disconnect alarms were active on (b)(6) 2021 at 11:46:25 ¿ 13:15:26 and were coincident with rsoc invalid faults occurring on both power cables and did not clear.The driveline was disconnected on (b)(6) 2021 at 13:00:38 and the controller was shut off at 13:15:26.There were no other notable alarms active in the log file.Pump operation was not affected.The controller was initially tested immediately began alarming.The power cables underwent continuity and insulation testing and did not pass.The power cables were cut open to inspect the condition of the wires.Fluid ingress was found and the orange (transmission communication), blue (receiving communication), and brown (battery gauge) wires were cut on the white power cable underneath the strain relief.The orange (not used), red (motor voltage out), and brown (battery gauge) wires were also cut underneath the strain relief on the black power cable.The power cables were replaced with test power cables in order to continue evaluation.After the power cable replacement, controller underwent preliminary and functional testing again and passed.The controller was able to operate as intended.The root cause of the reported event was conclusively determined to be caused by the broken wires.Incidental findings: fluid ingress, damaged power cables.Heartmate iii instructions for use, rev.C, section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook, rev.C, section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use and inspecting the system controller power cables for damage.Heartmate iii instructions for use, rev.C, section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook, rev.C, section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.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.The device history records were reviewed for the system controller (serial number: (b)(6)) and was found to pass all manufacturing and qa specifications before being shipped to the customer.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: 12796352
• MDR Text Key: 285169588
• Report Number: 2916596-2021-06392
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 85 KG