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

Model Number 106531US

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Mechanical Problem (1384); Material Deformation (2976); Protective Measures Problem (3015); Insufficient Information (3190)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a broken pin on the white power lead on the system controller.The patient was still able to connect to the mobile power unit and batteries, but has had unspecified potential alarms described as "phantom beeps." the site planned to exchange the patient's system controller in their next clinic visit.

Manufacturer Narrative

Manufacturer investigation conclusion: the reported event of a broken pin on the white power lead and beeping from the controller was not confirmed.The system controller (serial #: (b)(6)) was not returned for analysis.Multiple good faith efforts were sent to retrieve information on if the system controller was exchanged and the customer replied that the system controller has yet to be exchanged.A good faith effort was sent to retrieve information as to why the system controller has not been exchanged and when the expected exchange date is; however, no response was received.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the system controller (serial #: (b)(6)) and the system controller was found to pass all manufacturing and quality assurance specifications before being shipped to the customer on 09apr2020.Heartmate iii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly care for, maintain, and store the equipment for proper use.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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
• MDR Report Key: 11059827
• MDR Text Key: 223728889
• Report Number: 2916596-2020-06092
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/29/2021

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: 01/23/2023
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 7428014
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 03/26/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 79