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

Model Number	106762
Medical Device Problem Codes	Disconnection (1171); Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The previous driveline repair was reported in mfr report #2916596-2020-03843.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
Related manufacturer reference number: 2916596-2021-06881.It was reported that the patient presented in clinic with alarms while on battery power.It appeared to be no external power, despite patient claimed he walked out the door.Upon examination of the history, a pump stop was noted.The patient had a history of short to shield with an external repair in (b)(6) 2020.A log file review showed a pump stop event on (b)(6) 2021 at 07:01am while on using the power module and there were no further pump stops in the log.There were a few low voltage no external power events on (b)(6) 2021 at 12:33, 12:24, and 12:31 while using battery power and appeared to be an issue with the battery clips/14v batteries.There was potentially a weak connection between the battery clips and the power leads on the controller.The driveline repair in july 2020 was successful and the patient was on an ungrounded cable.There was not enough evidence to call this event a short to shield but the patient was planned to return in a couple weeks.The battery clips would be exchanged to see if that will resolve the low voltage/no external power issues.The battery clips were exchanged and the black power cord alarmed again for disconnection.The controller was replaced with suspected pin error.The alarm resolved following the controller exchange.
Additional Manufacturer Narrative
Manufacturer investigation conclusion: the reported event of atypical low voltage and power cable disconnect alarms as well as a no external power alarm active was confirmed via the submitted log file.The heartmate ii system controller (serial number (b)(6)) was returned to abbott for analysis and a log file was downloaded.The downloaded log file (labeled ab121407) and the submitted log file (labeled ab101213) contained partially combined overlapping data spanning approximately 4 days ((b)(6) 2021 ¿ (b)(6) 2021).The log file also captured an atypical no external power alarm active on (b)(6) 2021 at 12:24:24 and 12:31:23 due to a dual power cable disconnect.This was the result of both power leads measuring approximately 0 volts and being disconnected from external power simultaneously.The alarms resolved when external power was restored to the power leads and pump speed was not affected by the alarm.Additionally, the log file captured intermittent atypical power cable disconnect alarms active while connected to battery power due to the rsoc voltage in the black and white power cable dropping to approximately 0 volts.The alarms resolved when the rsoc voltage in the black and white power cable were restored to their expected voltage thresholds.The root cause of the no external power alarm was determined to be a user error in which both system controller power cables were disconnected from external power at the same time; however, the root cause of the power cable disconnect alarm could not be determined through this analysis.The device history records were reviewed and the records revealed the heartmate ii system controller (serial #: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.(b)(6) was shipped from abbott on (b)(6) 2021.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 no external power and power cable disconnect alarms.Heartmate ii instructions for use (ifu) (rev.C) section 3 ¿ ¿powering the system¿ and the heartmate ii patient handbook (rev.C) section 3 ¿ ¿powering the system¿ addresses how to properly switch between power sources.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: 12961470
• Report Number: 2916596-2021-06882
• Device Sequence Number: 5409663
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2022

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: Lay User/Patient
• Device Expiration Date: 10/30/2023
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 7747372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2021
• 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: 11/10/2021
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 12/08/2021
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2020
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 106 KG