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

Model Number	103696
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2024, a continuous sound alarm occurred at home, and the patient apparently replaced the system controller with a backup one.On (b)(6) 2024, the patient visited the hospital, and when hospital staff connected the controller to a power module, a pump off alarm occurred.Currently the patient was hospitalized and connected to batteries.The patient was asymptomatic.Log file review was requested, and the data displayed 57 low speed advisory alarms and 63 pump stop events during the roughly 2-minute length of the log file history.Speed drops were as low as 0 rpm.These events were followed by driveline disconnects where the driveline was disconnected from the controller indicative of a controller change as mentioned.This type of behavior had been linked to potential issues with the percutaneous lead.These issues appeared to be occurring while the ventricular assist device (vad) was connected to batteries and/or power module.It was communicated on (b)(6) 2024 that the patient's pump was exchanged with a heartmate 3, and the pump and 1 system controller were to return for evaluation.It was communicated on 28may2024 that the reason for the pump exchange was a suspected short-to-shield.The cause of the alarm at home could not be identified, and no particular troubleshooting steps were performed.There was no damaged noted to the percutaneous lead, and no images were available.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported of pump stop events can be confirmed.The evaluation of the returned system controller serial number: (b)(6) revealed multiple damaged printed circuit board (pcb) components.As a result, the controller was not able to operate a test pump when received.The data contained in the log file retrieved from the controller was consistent with the damage confirmed during analysis, there were few entries where the controller was unsuccessfully attempting to start the pump.A log file provided by the customer was reviewed.The log file captured two minutes of data, from the time stamp of day 2145, 12 hours and 48 minutes to day 2145, 12 hours and 50 minutes.The log file was filled with events where the system controller was unsuccessfully attempting to start the pump.These events were accompanied by elevated power and pi values and low speed hazard and low flow hazard alarms.The last recorded entries revealed that the driveline was disconnected which appears consistent with the reported controller exchange.In conclusion, the data contained in the log files and the damaged drive circuit components appeared consistent with the compromised driveline confirmed during the pump evaluation.The device history records were reviewed and the records revealed the system controller was manufactured in accordance with manufacturing or qa specifications.Patient handbook rev.D, operating manual rev.F, instructions for use rev.B covers all alarms (visual and audible) on the system controller and what action should be performed when they do occur.Explanation of the pump power values is described in the operating manual rev.F and instructions for use rev.B.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19488072
• Report Number: 2916596-2024-03181
• Device Sequence Number: 8583860
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: (01)00813024010630(17)201031
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 10/31/2020
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 6272767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2017
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 55 KG