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

Model Number	106762
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the patient's system controller was hot.They had a controller exchange on (b)(6) 2020.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the system controller overheating was unable to be confirmed.The heartmate ii system controller (serial number: (b)(6)) was not returned for analysis.Multiple good faith effort attempts were made requesting if the system controller will be returning; however, no response was received.The root cause for the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed for the system controller (serial number: (b)(6)) and was found to pass all manufacturing and quality assurance specifications before being shipped to the customer on (b)(6) 2019.Heartmate ii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook section 6 entitled caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.Heartmate ii instructions for use section 2 entitled ¿system operations¿ and heartmate ii patient handbook section 2 entitled ¿how your heart pump works¿ states that the acceptable temperature range for the system controller is 32°f - 104°f.It also cautions users to ¿not place the system controller on bare skin for an extended time.The system controller surface temperature can become uncomfortably warm, especially when the room temperature is above 104°f)¿.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 II SYSTEM CONTROLLER
• Common Device Name: 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: 12733074
• Report Number: 2916596-2021-06048
• Device Sequence Number: 11132822
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/18/2021
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/30/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 75 KG