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

Model Number 106762

Device Problems Alarm Not Visible (1022); Display or Visual Feedback Problem (1184); Electrical Power Problem (2925)

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

Event Date 09/15/2023

Event Type  Death  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that there were low voltage alarms appeared to improve after changing battery clips.The flow was not showing on the display but was showing under alarms and events.

Event Description

It was additionally reported that the controller was exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of unexpected low voltage alarm was confirmed via log file analysis.A review of the submitted log file captured intermittent low voltage advisory/low voltage hazard alarm events.The low voltage alarm events appear to be active because of the battery fuel gauge voltage values decreasing to the low limit threshold.The low voltage hazard alarm appears to be active when the 14v battery was disconnected from the white power cable.The intermittent alarms were consistently active because of the black power cable.Of note, there was a power exchange to the power module via power module patient cable and the captured voltage values were lower than expected (~14v).Additional information communicated that system controller (serial # (b)(6)) was exchanged as result of the alarm issue.No products will be returning for an evaluation.A root cause for the alarm issue was unable to be conclusively determined through this analysis.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.Heartmate ii lvas ifu rev.C (section 7), heartmate ii patient handbook rev.B (section 5), under alarms and troubleshooting, describes all alarms (visual and audible) and what action should be performed when they do occur.This includes ¿connect power¿ alarms.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).Low battery hazard alarm 1.Immediately connect to a working power source (power module or two fully-charged heartmate 14 volt lithium-ion batteries).2.If alarm persists, call your hospital contact immediately.Low battery advisory alarm 1.Promptly connect to a working or different power source (power module or two fully-charged heartmate 14 volt lithium-ion batteries).2.If alarm persists, call your hospital contact.Power cable disconnected alarm (¿connect power¿ visual message), which means one of the system controller power cables is disconnected from power.If it is the cable with the black connector, the top light comes on.If it is the cable with the white connector, the center light comes on.In section 3, under power the system, covers making or breaking connection between power sources.In section 2 of both manuals, covers replacing the running system controller with a backup controller.Also, under this section ¿performing a system controller self test¿, describes the use a daily system controller self test to check the audible and visual alarm indicators on the user interface, as well as the status of the backup battery for the system controller.The system controller self test is a loud and bright function.All of the audible and visual indicators should come on and ¿self test¿ should appear on the screen.Heartmate ii lvas ifu rev.C, heartmate ii patient handbook rev.B, both of which 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
• Type of Device: VENTRICULAR (ASSIST) DEVICE
• 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: 17839261
• MDR Text Key: 324529516
• Report Number: 2916596-2023-07083
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 813024011286
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/16/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2023
• Device Model Number: 106762
• Device Lot Number: 7624951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2020
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 97 KG