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

Model Number	106762
Medical Device Problem Codes	Disconnection (1171); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had multiple low voltage alarms.A review of the log files revealed several odd low power alarms while the patient was connected to batteries.The customer tried cleaning batteries and clips and had sent the patient new clips; the patient continued to get alarms.The alarms resolved after a controller exchange.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion.The reported event of low voltage alarms were confirmed via log file analysis.A review of the log file contained data spanning approximately 12 days ((b)(6) 2023 per timestamp).Throughout the entire log file, while connected to batteries, intermittent strings of low battery advisory alarms activated due to rsoc voltage fluctuations on the black power cable.The alarms did not resolve in the log file; however, the alarms did not affect the controller¿s ability to operate the pump at the set speed.No other notable alarms were active in the log file.The heartmate ii system controller (s/n: (b)(4)) was not returned for analysis.Per the provided information, the batteries and battery clips were cleaned, and new battery clips were provided, but the alarms reoccurred.The controller was exchanged, and alarms resolved.Multiple attempts were made to obtain additional information from the customer regarding if any product will be returned; however, no additional information was provided.A root cause for the reported event was unable to be conclusively determined through this analysis.Heartmate ii instructions for use, rev.C, section 7 - ¿alarms and troubleshooting¿ and heartmate ii patient handbook, rev.C, section 5 - ¿alarms and troubleshooting¿ address how to properly interpret and troubleshoot all system alarms, including low voltage alarms.Heartmate ii instructions for use, rev.C, section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook, rev.C, section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment.The patient handbook and ifu also 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.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Common Device Name: VENTRICULAR (ASSIST) 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: 16522820
• Report Number: 2916596-2023-01386
• Device Sequence Number: 6458358
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/10/2023

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: Health Professional
• Device Expiration Date: 07/10/2023
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 7644014
• 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: 02/17/2023
• Initial Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 85 KG