MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA; VENTRICULAR (ASSIST) BYPASS

Model Number 107754

Device Problem Complete Loss of Power (4015)

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

Event Date 06/06/2022

Event Type  malfunction  

Event Description

It was reported that the patient was seen in clinic on (b)(6) 2022.They had no external power alarms.The alarm on (b)(6) 2022 occurred from 330-524.The patient did not recall hearing any alarms.The patient also had no external power alarms on (b)(6) 2022 and (b)(6) 2022.Provided information stated the patient was unsure if the ac power cord came loose from the wall outlet but was likely the issue.Additionally, the patient had a v-lock connector, there were no environmental circumstances, and the patient did not deliberately disconnect power to the mpu.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of no external power alarms were confirmed via log file analysis.A review of the submitted log file contained data spanning approximately 49 days (26may22 ¿ 14jul22 per timestamp).On (b)(6) 2022 from 3:35:23 ¿ 5:24:45, (b)(6) 2022 from 3:17:31 ¿ 3:17:35, and (b)(6) 2022 from 6:40:49 ¿ 6:40:50, the no external power alarm activated while connected to the mobile power unit (mpu) due to both white and black lead voltages diminishing to ~3v.This was due to a loss of ac power and is consistent with an ac cord disconnection.The alarms cleared on its own shortly after each time after the cord was plugged in.The backup battery was able to provide power to the controller during these events.The alarm did not affect the controller's ability to operate the pump at the set speed.No other notable alarms were active in the log file.The mobile power unit (mpu) (s/n: (b)(4)) was not returned for analysis and remains in use.No additional documents or photos were submitted.A root cause for the reported event was unable to be conclusively determined through this analysis.Heartmate ii instructions for use, rev.C, section 7 ¿ ¿alarms and troubleshooting¿ and heartmate ii patient handbook, rev.C, section 5 ¿ ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including no external power alarms.The patient handbook and the instructions for use caution 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.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• 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: 15112892
• MDR Text Key: 304458549
• Report Number: 2916596-2022-12414
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 87 KG