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

Model Number	103696
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had possible water damage to the system controller and experienced a lot of power cable disconnects.It was noted that the patient experienced frequent low flow alarms with a normal pulsatility index (pi).The patient's system controller was exchanged and sent back for evaluation.It was also noted that the patient denied any symptoms and did not report hearing any alarms.Log files were not collected, and the cause of the alarms was not confirmed.As of (b)(6) 2023 there had not been any ongoing alarms.
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 investigative conclusion: incidental findings: atypical no external power alarm observed in the log file while patient was connected to power and not associated with a power source exchange the reported events of water damage and power cable disconnect alarms were both confirmed.A log file was extracted from the returned system controller (serial number (b)(6)) containing data spanning approximately 30 days ((b)(6) 2023 ¿ (b)(6) 2023 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.A string of atypical power cable disconnect alarms (alarms that were not associated with a power source exchange) was observed on (b)(6) 2023.The alarms appeared to have been caused by the voltage within the white power cable fluctuating above the alarm threshold, and the alarms resolved upon a power source exchange.The returned system controller was functionally tested and was found to perform as intended; atypical alarms were unable to be reproduced throughout all testing.The system controller¿s housing was opened, and the controller was inspected at a component level to check for signs of fluid ingress.The interior of the controller¿s housing appeared unremarkable.The controller¿s power cables were stripped, and small traces of fluid ingress were observed throughout both power cables.The observed fluid ingress did not affect the functionality of the controller throughout testing.The root causes of the reported events were unable to be conclusively determined through this analysis.Review of the device history record for system controller, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.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 heartmate ii patient handbook (rev.C, section 5 ¿alarms and troubleshooting¿) describes all alarms (visual and audible) and what action should be performed when they do occur, including the power cable disconnect, backup battery fault, and no external power alarms.To resolve the no external power alarm: 1.Immediately connect the system controller power cables to a working power source (functioning mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).2.Call your hospital contact immediately if connecting to power does not resolve the alarm.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, and to obtain replacements if needed.The heartmate ii patient handbook (rev.C, section titled ¿emergency contact list¿) cautions 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.
Additional Manufacturer Narrative
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: 17776781
• Report Number: 2916596-2023-06488
• Device Sequence Number: 6170279
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: 00813024010630
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 11/29/2023

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: 08/21/2023
• Device Model Number: 103696
• Device Lot Number: 7682523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2023
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 10/06/2023; 11/08/2023
• Initial Report FDA Received Date: 09/19/2023
• Supplement Report FDA Received Date: 10/27/2023; 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2020
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 110 KG