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

Model Number 106531US

Device Problem Mechanical Problem (1384)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/02/2021

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient had their controller exchanged on (b)(6) 2021 due to damage on the white power lead.The device was interrogated and found on alarms between nov2020 to 02jan2021.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damage to the white power lead was confirmed.A review of the downloaded log file spanned approximately 4 days ((b)(6) 20 ¿ (b)(6) 21 and (b)(6) 21 per time stamp).On (b)(6) 20 at 19:12 while connected to batteries, the power cable disconnect alarm intermittently activated due to an invalid rsoc fault associated with the white power cable being outside the expected voltage range.The alarm was not associated with a power source exchange and remained active through the rest of the log file.The alarm did not affect the controller's ability to operate the pump at the set speed.No other notable alarms active in the log file.System controller, serial (b)(6), returned without being able to communicate to the system monitor.The power cables were replaced in order to continue with testing.The cable jacket and shielding of the cables were stripped revealing no damage to the underlying wires under the jacket tears; however, there was fluid ingress found in the cables.Many cables had slightly high resistances and some had no continuity.The white connector was almost detached from the cable and had several severed wires including the orange and blue wires which are used for communication.The power cable was swapped and the controller passed all testing; it was able to support pump function for an extended period of time.A root cause for the reported damage cannot be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.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.Heartmate 3 instructions for use section 8-¿equipment storage and care¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly take care and maintain the integrity of the system controller connectors and cables.Heartmate 3 instructions for use section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot power cable disconnect alarms.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
• MDR Report Key: 11181028
• MDR Text Key: 227942584
• Report Number: 2916596-2021-00097
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/12/2022
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6940209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 131