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

Model Number 106762

Device Problems Alarm Not Visible (1022); Disconnection (1171); Electrical Power Problem (2925); Failure of Device to Self-Test (2937); Data Problem (3196); Complete Loss of Power (4015)

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported that the patient was sitting and asymptomatic when a pump stop alarm occurred.The flow and speed also dropped.There was no significant weight change and no trauma to the driveline.Multiple attempts were made to obtain log files but only 2 files were exported instead of 5.Log files were submitted for review and captured 3 pump stops and 2 low speed advisories while on support from batteries.In addition, the log captured numerous odd power cable disconnects, low power advisories, and backup battery fault alarms.The white and black power cable connectors were also showing lower relative state of charge voltage values than expected.The patient was admitted for red heart alarms, speed drops to lower than 2000 revolutions per minute and pump stop alarms but was hemodynamically stable.Additional log files were submitted for review.There were no external power alarms from the morning of on (b)(6) 2023.The patient had been connected to wall power.The speed settings were 9000 revolutions per minute, flows 4.6 liters per minute, pulsatility index 7.8, and power 5.0 watts.Numerous no external power events were noted throughout the log, and these seemed to occur when the black power lead was disconnected.It was suggested to reseat/replace the backup battery in the system controller to resolve the low voltage and no external power events.Measurements of the exit site to the proximal portion of the past driveline repair were submitted for review and measured 2 and 7/8 inches from exit site to the start of the repair, which was not enough room for an additional repair.It was thought that the patient had a phase to phase short.The patient was put on an ungrounded cable and immediately got a no external power alarm when the black cable was disconnected.It was noted that putting the patient on an ungrounded cable in the past did not prevent alarms.The patient was scheduled to get an echocardiogram (echo) and would get repeated driveline x-rays since previous images were not available.Plain films were submitted for review and no areas of shield breakdown in the external or internal portions of the driveline were seen.A computed tomography scan of chest, abdomen and pelvis would also be performed.On (b)(6) 2023, a controller self-test was performed and there were no visual or audible alarms on the system controller, however, the power base unit the patient was attached to alarmed appropriately.Log files were submitted for review again and captured continued low power, backup battery, and no external power alarms.It was advised to swap the system controller to resolve the self-test failure, as the issues appeared to be related to that.The log did not capture any new pump stops or speed drops since on (b)(6) 2023.The x-ray provided only showed a part of the external driveline and was unremarkable.On (b)(6) 2023 a heartmate ii to heartmate 3 pump exchange was successfully performed.Related manufacturer reference number for the pump: (b)(4).

Manufacturer Narrative

Section b5: the patient's previous driveline repair was reported in mfr # 2916596-2020-05001.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Voluntary medwatch number 2201100000-2023-8024 manufacturer's investigation conclusion: the submitted log files contained data spanning 23 days combined ((b)(6) 2023 ¿ (b)(6) 2023 per the timestamp).Pump stop events and associated low speed advisories, low speed hazards, low flow hazards, and pump off alarms were captured on (b)(6) 2023 and (b)(6) 2023; these events are consistent with a compromised driveline and are addressed under the pump investigation intermittent no external power alarms were captured throughout the log files when the black power cable was disconnected from external power despite the white power cable still being connected to an external power source.The no external power alarm resolved each time the black power cable was reconnected to external power.Although not confirmed, these alarms are consistent with the backup battery not detecting the presence of the external power source connected to the white power cable and may occur due to one of the backup battery pins not being fully engaged in the backup battery ribbon cable connector.A low voltage hazard alarm was captured on (b)(6) 2023 at 13:58:45 due to the relative state of charge (rsoc) voltage on both power cables dropping to 0v at the same while connected to 14v batteries; this occurred at the same time as a pump stop event and appears to be associated with the compromised driveline issue.A backup battery fault alarm associated with a backup battery signals faulted error was captured on (b)(6) 2023 from 22:17:28 to 22:17:29; the alarm resolved on its own.The log file also captured intermittent power cable disconnect alarms that were not associated with power source exchanges due to the rsoc voltage level dropping while connected to 14v batteries.The atypical alarms occurred on both the black and white power cables and resolved on their own each time due to the voltage returning to its appropriate level.Technical services recommended exchanging the system controller to resolve the atypical alarms and the reported self-test issue.A heartmate ii to heartmate 3 pump exchange was performed due to the compromised driveline issue.The heartmate ii system controller that was in use was not returned for evaluation.Multiple requests for additional information (including if the cause of the atypical alarms was determined, if any troubleshooting steps were performed, and if any product would be returned for evaluation); however, no response was received.The root cause of the reported events could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate ii patient handbook (rev.C), under section 5 ¿alarms and troubleshooting¿ and heartmate ii instructions for use (ifu) (rev.C), under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), and the actions to take if the alarms cannot be resolved.Heartmate ii patient handbook (rev.C) section 6 "caring for the equipment" and heartmate ii instructions for use (ifu) (rev.C) section 8 "equipment storage and care" describe how to care for and clean all equipment.Heartmate ii patient handbook (rev.C) section 10 and heartmate ii instructions for use (ifu) (rev.C) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate ii lvad.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate ii patient handbook (rev.C) section 2 ¿how your heart pump works¿ and heartmate ii instructions for use (ifu) (rev.C) section 2 ¿system operations¿ explain how to perform a system controller self test.Heartmate ii patient handbook (rev.C) 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.

Manufacturer Narrative

Section d1, brand name: corrected.Section d4, catalog number: corrected.Section d4, primary udi number: corrected.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18239820
• MDR Text Key: 329555782
• Report Number: 2916596-2023-08087
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(21)PCX-19467(17)230710
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2024

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: 07/10/2023
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 7644014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 05/23/2024
• Supplement Dates FDA Received: 06/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 81 KG