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

Model Number 106762

Device Problems Electrical Power Problem (2925); Material Deformation (2976)

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

Event Date 01/12/2022

Event Type  malfunction  

Event Description

It was reported that the patient's controller was replaced due to concerns of damaged power cables causing low voltage hazard alarms.Log file analysis captured unusual voltage readings on both battery and wall power; these occurred intermittently throughout the entire log file.The patient had no further issues after their controller change.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damage on the controller power cables was not confirmed.The reported event of low voltage advisory/hazard alarms and atypical voltage readings was confirmed via analysis of the submitted log file.The log file contained approximately 21 days of data (20dec2021 ¿ 10jan2021 per the timestamp).Decreased relative state of charge (rsoc) and bus voltages were observed on both power cables while connected to the mobile power unit (mpu) and the 14v batteries.While connected to 14v batteries, the rsoc voltage fluctuated and dropped below the low voltage thresholds throughout the log file, activating low voltage advisory/hazard alarms not associated with regular battery depletion; the atypical alarms were observed on both power cables and resolved shortly after activating each time.While connected to the mpu, the rsoc voltage did not decrease below the low voltage threshold to activate any associated alarms; the rsoc voltage ranged from 11.4 v to 12.6 v while on mpu support.The driveline was disconnected on 10jan2022 a 9:03:52 to exchange the system controller.There were no other notable alarms throughout the log file.The pump maintained a speed above the low speed limit throughout the log file.No pictures of the damage on the power cables were submitted for review and additional information provided stated that the heartmate ii system controller (serial number: (b)(6) ) would not be returned for evaluation.It was also reported that the power cables had visible damage and that the patient did not report further issues after the controller was exchanged.The root cause of the reported events could not be conclusively determined through this analysis; however, the reported damage on the power cables may have contributed to the reported alarms and voltage drops.The device history records were reviewed and the records revealed that the heartmate ii system controller, serial number (b)(6) , was manufactured in accordance with manufacturing and qa specifications.The heartmate ii system controller was shipped to the customer on (b)(6) 2018.Heartmate ii patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate ii instructions for use (ifu) section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the low voltage advisory/hazard alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate ii patient handbook section 6, entitled "caring for the equipment", describes how to care for and clean all equipment, including the system controller, system controller power cables, 14v batteries, battery clips.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate ii lvad, including inspecting the system controller power cables for dirt, grease, or damage.Heartmate ii patient handbook 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.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) 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: 13358627
• MDR Text Key: 286941863
• Report Number: 2916596-2022-00322
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• 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: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2021
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 6487676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 83 KG