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

Model Number 103696

Device Problems Disconnection (1171); Electrical Power Problem (2925); Material Deformation (2976); Unexpected Shutdown (4019)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  malfunction  

Event Description

It was reported that the patient had passed away during a supposed controller changeout.The log files were sent for review and it appeared that there were several power cable disconnects/low voltage advisories prior to a pump stop due to both power sources being disconnected.Family reported the controller fault was the reason for the controller exchange, but none were seen in the log files.The power was re-applied and the pump ran for 1 hour and 14 minutes.Then a loss of power to the controller again.The power was reapplied and the pump then ran for 8 minutes until the driveline was disconnected from the pump.An inspection of the controller noted that the black lead had remnants of another connection broken off in the connector itself that would prevent a reconnection to another power source.There was no way to know whether this happened before or during the changeout.Additionally, a controller clock reset appears to have been related to another low voltage/ loss of power event.It could not be determined whether these occurred on the power module patient cable or batteries.The controller would be sent back for further analysis, with the broken connection reinserted back into the black lead as found.Manufacturer reference report number: 2916596-2022-10903.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of ¿several power cable disconnects/low voltage advisories¿ was confirmed via log file analysis.Also, the reported event of the ¿black lead had remnants of another connection broken off in the connector¿ was confirmed with the returned device.Visual inspection revealed the black power cable appeared to have a piece of a connector lodged within the locking nut.The lodged piece was removed and appeared to be the threaded section from the 14v battery clip connector.For testing purposes, the threaded section of the 14v battery clip was screwed within the system controller black cable connector.The black connector was not able to fully mate with test 14v power module patient cable connector.There was partial contact with the metal pins and power was supplied; however, without being secured in place, the connector would become disconnected from the test 14v power module patient cable.With the lodged piece removed, the system controller was tested with laboratory equipment and was found to function as intended.The device passed the functional test procedure, confirming that all visual and audible alarms activated when they were induced.According to the data captured in the log file, the unexpected power cable disconnect alarm is consistent with the lodged piece found within the black power connector.The lodged piece in the black power connector prevented the connectors to fully secure and had the potential to become disconnected, which can result in a loss of power if the white power cable was disconnected.The analysis could not determine how the damaged threaded section of the 14v battery clip became lodged within the system controller locking nut.Device history record indicated the device was manufactured in accordance to mfg and qa specifications.System controller (serial # epc-44697) was shipped to the customer on 19apr2019.Patient handbook rev.D (p.18 ¿ p.22), operating manual rev.F (section 8), instructions for use rev.D (section 12.4) covers all alarms (visual and audible) on the system controller and what action should be performed when they do occur.Under low voltage advisory and low voltage hazard alarms.Low voltage advisory alarm is a yellow battery symbol with 1 beep every 4 seconds.Low voltage is a red battery with continuous audio tone.Under power cable disconnected.One of the power leads is disconnected.Check for loose power leads.If on pm power, check that power lead is not disconnected or damaged.Check that the system controller power lead is damaged.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the log file captured intermittent low voltage advisory (yellow battery) alarm events related to transient battery fuel gauge voltage values when the 14v batteries reach the low limit threshold.It was noted the 14v batteries were depleting as expected, with the runtime estimated to be approximately 12 hours from full to the low limit threshold.The alarm cleared when a power exchange was performed.From day 200 hour 22 minute 1 to day 200 hour 22 minute 23, there were intermittent unexpected power cable disconnect alarm events captured with the white power cable connected to the 14v batteries/clips and the black power cable connected via the 14v power module patient cable to the power module.Power was applied to the power cables with the timestamp at day 0 hour 0 minute 0 suggesting a complete loss of power to the system controller.At day 0 hour 1 minute 14, a power cable disconnect alarm was captured with the white power cable connected to the 14v batteries/clips and the black power cable connected via the 14v power module patient cable to the power module.A second complete power loss event was captured with the pump speed value captured at 7,620 rpm.At day 0 hour 0 minute 8, the driveline appeared to have been disconnected and remained disconnected.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: 14362120
• MDR Text Key: 291833050
• Report Number: 2916596-2022-10904
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2022

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: 03/19/2022
• 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
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: 06/29/2022; 09/14/2022
• Supplement Dates FDA Received: 07/20/2022; 09/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2019
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 76 KG