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

Model Number 103696

Device Problems Alarm Not Visible (1022); Complete Loss of Power (4015); Unexpected Shutdown (4019)

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

Event Date 12/17/2022

Event Type  malfunction  

Event Description

It was reported that the patient's spouse found the patient passed away in bed on (b)(6) 2022.The log files noted that the system controller had completely lost power resulting in a pump stop and that the time stamp restarted.The log files also noted high speeds of as high as 10000 rpm.The patient was found to be on both batteries and wall power due to a possible phase to phase short or possibly broken wires.There were also cell battery low events in the log file indicating that the power to the controller lights and alarms was lost.The cause of death, whether the death was device related, and whether the device operated as expected are all unknown.

Manufacturer Narrative

Related mfr: 2916596-2022-16082.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Section b: date of death should have been redacted from initial report.Manufacturer¿s investigation conclusion: the reported event of a complete loss of power to the controller resulting in a pump stop was not able to be confirmed.Multiple requests for additional information regarding the event have been made and as a result four log files were received for review.The data contained in all log files was identical, indicating that all log files were retrieved from the same system controller.The first entries captured in all log files revealed the manufacturing default speed of 6000 rpm.The speed was adjusted from 6000 rpm to 8800 rpm and then to 9600 rpm.It appears that after the speed was adjusted to 9600 rpm, the pump was briefly connected; however, the speed did was not captured above 1960 rpm.The next entries suggested that both power cables were disconnected from external power and then reconnected.The remaining data revealed that the pump was briefly connected (2090 rpm) and disconnected.The pump was connected again, the speed reached 8990 rpm, then it dropped to 1020 rpm and increased to 9800 rpm.The low speed hazard alarm was recorded through the entire log file besides the entries where the speed was between 8990-9800 rpm (above the low speed limit).The pump was disconnected and it was never connected again trough the remaining entries.Although the pump was not connected, the speed was adjusted multiple times (from 9800 rpm to 9400 rpm, from 9400 rpm to 9800 rpm, from 9800 rpm to 10000 rpm).The power source during the events captured in the log file was not able to be conclusively determined, since the controller¿s software was 4.13 and the rsoc (relative state of charge) values are not available in this software version.The log file also contained multiple controller cell low alarms.The events captured in the log file suggested that they were extracted from a backup controller and did not appear to be related to the reported event.The investigation was unable to determine when these events/alarms were generated or if the events were related only to the initial setup of the device.Per the additional information, the family provided numerous controllers when they returned the equipment.It was unclear which controller supported the patient at the time of the event.(b)(6) was the only controller which was saved and all the others have been discarded.The (b)(6) will not be returned for evaluation.The patient handbook and operating manual cover all alarms (visual and audible) on the system controller and what action should be performed when they do occur.The patient handbook section ¿the system controller¿ explains the warning lights and sounds (including red heart, red battery, yellow battery and controller cell) sections ¿making and breaking connections to battery power¿, ¿changing from pm power to batteries¿, ¿making and breaking connections to pm power¿ and ¿changing from batteries to pm power¿ addressed the different power sources and how to properly switch between them.The patient handbook contains important warnings regarding the operating and safety aspects of heartmate products.Reference some of the warnings below: understanding the operating and the safety aspects of heartmate products is essential for safe and successful use.All users (including clinicians, patients, and caregivers) must be trained on system operation and safety aspects before use.The pump will stop if the system controller is disconnected from the percutaneous lead going through your skin.If this happens, reconnect the lead as quickly as possible to restart the pump.At least one system controller power lead must be connected to a power source (batteries, pm, or epp) at all times.If both system controller power leads are disconnected at the same time, your pump will stop.Losing power will make the pump stop.Power must be restored right away to restart the pump.Plug the pm only into properly grounded (3-prong) outlets dedicated to pm use.Do not use an adapter (cheater plug) for ungrounded outlets or multiple portable socket outlets (power strips) or you may get a serious electric shock or the pump may stop.If the pm is without electrical power for approximately 18-36 hours, the backup battery may be damaged.Keep the pm plugged into electrical power at all times.Important warnings related to pump stops are also described in the operating manual.The shop orders were reviewed and the records revealed the system controller was manufactured in accordance with manufacturing or qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16184519
• MDR Text Key: 309298692
• Report Number: 2916596-2023-00350
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010630
• UDI-Public: 00813024010630
• 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: 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2013
• Device Model Number: 103696
• Device Catalogue Number: 103696
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2010
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 94 KG