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

Model Number 103696

Device Problems Alarm Not Visible (1022); Disconnection (1171); Electrical Power Problem (2925)

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

Event Date 03/16/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there were low battery alarms at 14:00 and 19:00 (b)(6) 2024.Around 14:00, it was reported that the battery was switched to 14:50.When the low battery came out at 19:00, the patient reported that there was no alarm, and the power was not switched on.The patient's information and data were different.It seemed that power cable disconnect and low voltage advisory was recorded while the battery was connected.The patient was asymptomatic.Log files were submitted for review and displayed low battery advisories (including multiple power cable disconnects) while tethered on batteries as mentioned.There were no other unusual events seen within the log file.The mechanical circulatory support (mcs) equipment is operating as expected.

Event Description

It was reported that nothing was done to cause an alarm.The system controller was alarming appropriately, and no alarms were reported after the power module cable was replaced.

Manufacturer Narrative

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

Manufacturer Narrative

Section d3: manufacturer corrected.Section d1: brand name was corrected.Section d4: udi and catalog number were corrected.Section e1: customer site was (b)(6) hospital.Reporter phone number and email were not provided.Section g1: contact corrected.Section h6: medical device problem code corrected.Manufacturer¿s investigation conclusion: the reported event of atypical power cable disconnect and low voltage advisory alarms was confirmed via log file analysis.The system controller (serial number: (b)(6) was not returned for analysis; however, log files were submitted with events spanning approximately 6 days (from day 1814, hour 2, minute 17 to day 1819, hour 21, minute 59 per timestamps).On day 181, hour 6, minute 51, while connected to 14v li-ion battery power, an atypical power cable disconnect alarm activates.There are several additional power cable disconnect alarms occurring on both 14v li-ion batteries and the power module up until day 1819, hour 17, minute 50.The connected 14v li-ion batteries at the time of these events appear to be fully charged, and the relative state of charge (rsoc) values of the 14v li-ion batteries remain at their expected values.A string of low voltage advisory alarms while connected to 14v li-ion batteries activates at day 1814, hour 20, minute 51.Another low voltage advisory alarm activates at day 1818, hour 3, minute 18.These low voltage alarms are atypical in nature because the alarm continues to activate and clears without a disconnection and reconnection of the power source.There were no other notable events observed in the log file.Pump operation was not affected.Additional provided information stated that the system controller was alarming appropriately, and that the cause of the power cable disconnect and low voltage alarms was unknown.The root cause for the reported event cannot be conclusively determined through this analysis.Device history records were reviewed for the system controller and showed no deviations from manufacturing or qa specifications.Heartmate ii instructions for use section 12.4 entitled ¿alarms screen¿ details how to navigate and utilize the system monitor alarms screen, including hazard and advisory alarms.Heartmate ii operating manual section 8.3.6 entitled ¿alarms¿ addresses how to properly interpret and troubleshoot all system alarms including power cable disconnect and low voltage advisory alarms.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER, US, EP
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18988359
• MDR Text Key: 338730760
• Report Number: 2916596-2024-01883
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: (01)00813024010630(17)210822
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2024

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: Lay User/Patient
• Device Expiration Date: 08/22/2021
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Device Lot Number: 6598026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 05/08/2024; 06/19/2024
• Supplement Dates FDA Received: 05/29/2024; 06/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2018
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 49 KG