MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number 106531US

Device Problems Disconnection (1171); Electrical Power Problem (2925)

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

Event Date 07/04/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of atypical low voltage/power cable disconnect alarms was confirmed via review of the submitted log file, containing approximately 1 day of data (04jul2022 to 05jul2022 per timestamp).These atypical alarms were observed intermittently throughout the data, either when the rsoc within one cable fluctuated below the alarm threshold, or while the white power cable was disconnected from external power sources.During these disconnections, the rsoc and voltage of the black power cable were observed to fluctuate below the designed low voltage alarm thresholds, triggering either a low voltage advisory or hazard alarm.These alarms cleared shortly after the reconnection of the white cable each time.The ability of the pump to operate at the set speed was unaffected, as it maintained a speed above the low speed limit throughout the data.The heartmate 3 system controller serial number: (b)(4) was not returned for evaluation.The provided information indicated that the controller was exchanged resolving the alarms and the controller would not be returned for evaluation.The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed that the heartmate 3 system controller, serial number (b)(4), was manufactured in accordance with manufacturing and qa specifications.The heartmate 3 patient handbook rev.D - section 5 ¿alarms and troubleshooting¿ covers all alarms (visual and audible) that are associated with the system controller, including power cable disconnect and low voltage alarms, and the actions to take if the alarm cannot be resolved.The heartmate 3 patient handbook rev.D - section 6 ¿caring for the equipment¿ describes how to properly care for and clean all equipment, including the system controller and its power cables.The patient handbook cautions the user 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.

Event Description

It was reported that the patient had low voltage advisory alarms starting 24-48 hours before they came into the clinic on (b)(6) 2022.The patient said that when they disconnected the white power cable the system controller read low battery alarm and connect to power.The patient reported that this had been happening on and off but felt like it occurred more frequently in the 24 hours before they came to the clinic.The batteries and battery clips all appeared to be intact and clean with no visible damage.All the wires and the white power cable also appeared to be intact.A review of the log files by technical services found several low power/power cable disconnect alarms when the patient was connected to battery and wall power that appeared to be coming only from the white power lead.A system controller exchange was planned for once the patient was stable and inr was therapeutic.The system controller was exchanged on (b)(6) 2022 which resolved the alarms.

• Brand Name: HEARTMATE 3 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15095445
• MDR Text Key: 304808750
• Report Number: 2916596-2022-12280
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013235
• UDI-Public: 00813024013235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• 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
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/10/2021
• Device Model Number: 106531US
• Device Catalogue Number: 106531US
• Device Lot Number: 6798538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2018
• 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: 75 YR
• Patient Sex: Male
• Patient Weight: 74 KG