MAUDE Adverse Event Report: THORATEC CORPORATION HMII, G2.3, POCKET CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number	106762
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient's controller alarmed "call hospital contact".The patient's wife exchanged the controller.The controller exchange resolved the alarm but the patient's wife was unable to turn off the controller when it was no longer in use.The controller would not respond to any button being pressed.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Incidental findings: superficial jacket damage - cut in the white power cable.Manufacturer's investigation conclusion: the reported event of a call hospital contact message and red heart alarm was confirmed via evaluation.A review of the downloaded log file contained data spanning approximately 9 days (12may2023 ¿ 20may2023, 01jan2001 per timestamp).Starting 20may2023 at 16:45:30, the pump speed fell to 0 rpm due to the bus voltage and phase values falling to 0.The bus voltage and phase values intermittently fluctuated until 20may2023 at 17:08:35.On 20may2023 at 16:45:30 and 16:54:31, backup battery not installed alarms activated.In addition, from 16:47:30 ¿ 16:54:36, driveline disconnect alarms activated.These alarms did not appear to be true physical disconnections due to a potential shorted condition within the controller.The log file did not capture the resolution of the pump stop or the driveline being disconnected from the controller before it was exchanged.This is consistent with the controller entering backup mode.By design, the system controller does not record events while in backup mode.No other notable alarms were active in the log file.The heartmate ii system controller (s/n: (b)(6)) was returned for analysis.The system controller underwent functional testing.Upon connecting to power, a connect driveline message and red heart alarm were active.The driveline was connected, and a call hospital contact message activated.The pump was unable to start.The controller was disassembled and residue consistent with dried fluid ingress and corrosion was observed on multiple main printed circuit board (pcb) components.The damaged components pertain to circuitry that controls the emergency backup battery, the driveline phases, and communication with the motor that regulates motor speed.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 controller fault alarms.The heartmate ii patient handbook, rev.C, section 10 ¿safety checklists¿, instructs users to regularly inspect their equipment for damage, including damage to the system controller¿s power cords, and to obtain replacements if needed.The heartmate ii patient handbook, rev.C, instructs users to never submerge their equipment, including their system controller, underwater.The patient handbook also instructs users to never expose their equipment to liquids or fluids of any kind.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 quality assurance (qa) specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HMII, G2.3, POCKET 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: 17366622
• Report Number: 2916596-2023-05244
• Device Sequence Number: 6608361
• Product Code: DSQ
• UDI-Device Identifier: 00813024013013
• UDI-Public: 00813024013013
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2023

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: Lay User/Patient
• Device Expiration Date: 03/17/2024
• Device Model Number: 106762
• Device Catalogue Number: 10005080
• Device Lot Number: 7917288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/20/2023
• Supplement Report FDA Received Date: 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2021
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 113 KG