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 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The log file review captured a no external power event on 14apr2022 and 27may2022 which were cause by an interruption of power to the mobile power unit (mpu).It was reported that the patient was using the locking version of the mpu ac power cord.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of no external power alarms while connected to the mobile power unit (mpu) was confirmed via analysis of the submitted log file.The submitted log file contained approximately 83 days of data (b)(6) 2022 per the timestamp).The log file captured no external power alarms on (b)(6) 2022 from 20:19:38 to 20:19:39 and on (b)(6) 2022 at 18:44:09 due to losses of external power while connected to the mpu.The alarms resolved once external power to the mpu was restored.The system controller backup battery supported the system during the losses of external power without any issues.No other notable alarms were observed in the log file.The alarms did not affect the controller¿s ability to operate the pump at the set speed.Additional information provided communicated that the patient is using a locking version of the mpu ac power cord.Multiple attempts were made to obtain additional information (including if the mpu ac power cord became loose at the wall outlet or from the back of the unit, or if there were and environment circumstances that would have affected ac power at the time of the event); however, no response was received.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 mobile power unit (mpu) was manufactured in accordance with manufacturing and qa specifications.The mpu was shipped to the customer on (b)(6) 2020.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including no external power alarms, and the actions to take if the issue does not resolve.Heartmate 3 instructions for use section 3 ¿ ¿powering the system¿ and heartmate 3 patient handbook section 3 ¿ ¿powering the system¿ explains how to properly use the mobile power unit (mpu) and that in the event the mpu loses power the patient is instructed to switch power sources as the backup battery in the system controller will only temporarily power the pump.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.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: 15107543
• MDR Text Key: 304600039
• Report Number: 2916596-2022-12166
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model 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: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2019
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 44 KG