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

Model Number 106762

Device Problems Low Audible Alarm (1016); Disconnection (1171); Display or Visual Feedback Problem (1184); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/24/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of atypical power cable disconnect alarms was confirmed via the provided log file.However, the reported events of the controller sounding faint, the controller¿s white cable being kinked, and the controller having dim green pump leds, were not confirmed.The provided log file contained data spanning approximately 2 days ((b)(6) 2022 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.Atypical power cable disconnect alarms (alarms not associated with a power source exchange) were observed throughout most of the data while batteries were in use.The alarms appeared to have been caused by the rsoc within either cable briefly fluctuating below the alarm threshold.No other notable events were observed.The system controller (serial number (b)(4) was not returned for analysis.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)(4), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The controller was shipped to the customer on (b)(6) 2017.The heartmate ii patient handbook (rev.F, ¿safety checklists¿) instructs users to regularly inspect their equipment for damage, including damage to the system controller¿s power cords and speakers, and to obtain replacements if needed.The heartmate ii patient handbook (rev.F, ¿alarms and troubleshooting¿) describes all alarms (visual and audible) and what action should be performed when they do occur, including alarms associated with power cable disconnect conditions.The heartmate ii patient handbook (rev.F, ¿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.

Event Description

It was reported that the patient had been experiencing power cable disconnect events.The controller alarmed when the patient bent over or slouched.The white cable was kinked due to the patient's lvad (left ventricular assist device) shirt.It was also noted that the controller sound was very faint and the pump running symbol was dim.The battery clips were pretty dirty but were cleaned.The driveline had exposed wires but this damage was covered with rescue tape.Log files confirmed many atypical power cable disconnect events while connected to battery power from (b)(6) 2022.These alarms resolved with the controller and battery clip exchange.Related manufacturer report number: 2916596-2022-10710.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: 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: 14455320
• MDR Text Key: 292173114
• Report Number: 2916596-2022-10711
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2020
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 6069618
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 159 KG