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

Model Number 106017

Device Problems No Audible Alarm (1019); Electrical /Electronic Property Problem (1198); Mechanical Problem (1384); Decreased Pump Speed (1500)

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

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient experienced speed drops below low speed limit without alarm, increases in power up to 18 w, and a replace system controller message.Further troubleshooting led to the replacement of the patient cable and system controller, which resolved the power issues.Patient continued to have pump stops on wall power, but not batteries.Hypothesis was that there is still at least a short to shield internally.The patient was switched to their backup system controller and no further alarms have been noted.Related manufacturer report number: 2916596-2022-11165, and 2916596-2022-11458.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a replace controller alarm was confirmed via log file analysis.A review of the log files contains overlapping data spanning approximately 28 days ((b)(6) 2022 per timestamp).Starting (b)(6) 2022 from 13:37:23 - 13:37:42, (b)(6) 2022 from 3:29:24 - 3:29:27, (b)(6) 2022 from 13:55:42 ¿ 13:55:44 and 17:20:29 ¿ 20:22:41, and (b)(6) 2022 from 7:01:14 ¿ 7:01:22, while connected to the power module, the pump struggled to maintain the set speed resulting in low speed operations and intermittent pump stops.On (b)(6) 2022 at 20:22:04, a replace controller fault activated due to a backup processor fault.The alarm cleared shortly after activating.The driveline was disconnected on (b)(6) 2022 at 7:26:20 for exchange.There were no other notable alarms active in the log file.The heartmate ii system controller (s/n: (b)(6)) was returned for analysis and functionally tested.The replace controller alarm was unable to be reproduced.The system controller was able to operate as intended during analysis without issue.A root cause for the reported event was unable to be conclusively determined through this analysis.During the investigation there were incidental findings of driveline fault alarm and no external power alarms.Device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.Heartmate ii instructions for use section 7 - ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 - ¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot all alarms, including driveline fault, power cable disconnect, no external power, and replace system controller alarms.Heartmate ii instructions for use section 8 - ¿equipment storage and care¿ and heartmate ii patient handbook section 6 - ¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.The patient handbook cautions the 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, EU
• 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: 14594227
• MDR Text Key: 293285195
• Report Number: 2916596-2022-11459
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

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: 06/27/2022
• Device Model Number: 106017
• Device Catalogue Number: 106762
• Device Lot Number: 7104629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/18/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2019
• 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: 33 YR
• Patient Sex: Male
• Patient Weight: 83 KG