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

Model Number	106762
Medical Device Problem Codes	Electrical Power Problem (2925); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had many low voltage alarms as well as visible damage noted on the black power cable.The controller was exchanged and no plan for returning the controller was made.The alarms resolved with controller exchange and no alarms were heard on the new controller.A review of the log files revealed odd strings of low power advisory and power cable disconnects alarms.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported events of low voltage alarms, power cable disconnect alarms, and damage to the black power cable were confirmed via log file analysis and customer submitted photo.A review of the submitted log file contained data spanning approximately 3 days (25jul22 ¿ 27jul22 per timestamp).From 25jul22 at 9:46:06 to the end of the log file, while connected to batteries and the mobile power unit, atypical strings of power cable disconnect alarms intermittently activated due to rsoc voltages fluctuating outside the expected voltage range on both power cables.These events were coincident with atypical strings of low voltage alarms occurring on battery power throughout the log file.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.Visual inspection of the customer submitted photo revealed a tear in outer jacket of the black power cable exposing the underlying mesh shielding.No damage to the underlying wires can be observed.Provided information stated the low voltage and power cable disconnect alarms resolved following a controller exchange.A root cause for the reported events was unable to be conclusively determined; however, the damage to the power cable could have contributed to the reported alarms.Heartmate ii instructions for use, rev.C, section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook, rev.C, section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including low voltage and power cable disconnect 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, 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.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: 15158470
• Report Number: 2916596-2022-12684
• Device Sequence Number: 17423212
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/03/2022

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: 06/19/2021
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 6556265
• 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: 07/28/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG