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 07/03/2022

Event Type  malfunction  

Event Description

It was reported that on the morning of (b)(6) 2022, the patient noted that while on the mobile power unit (mpu), the plug came unplugged from the wall.The event log recorded no external power events on (b)(6) 2022 which were caused by the power to the mpu being briefly interrupted.The emergency backup battery was used to support the system during these events.The cause of the low voltage and replace backup battery alarms was the cord being pulled from the wall while the patient was on mpu and the mpu placement was adjusted to prevent the cord from coming out of the wall.The mpu has a v-lock connector and that it did not come loose from the wall or the back of the unit.The mpu was not removed from service.

Manufacturer Narrative

Patient's gender was requested but was not provided due to hospital policy.Manufacturer's investigation conclusion: the reported event of no external power alarms was able to be confirmed.The mobile power unit (mpu) (serial number: (b)(4)) was not returned for analysis; however, a log file was submitted for review.A review of the submitted log files showed events spanning approximately 14 days ((b)(6) 2022 per timestamp).No external power alarms coincident with a loss of ac power were active on (b)(6) 2022 from 13:49:33 ¿ 13:49:39, on (b)(6) 2022 from 12:25:17 ¿ 12:25:22, and on (b)(6) 2022 from 08:23:38 ¿ 08:23:41 while the controller was connected to the mpu.The backup battery was able to provide power to the system during the alarms.The alarms cleared once power was restored.There were no other notable alarms active in the log file.Pump operation was not affected.The root cause of the reported event of no external power alarms on (b)(6) 2022 were reported to have been caused by the ac power cord coming loose from the outlet.The root cause of the other reported no external power alarms was unable to be conclusively determined through this investigation.The device history records were reviewed for the mpu (serial number: (b)(4)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on (b)(6) 2021.Heartmate iii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook (doc.#10006136, rev.D) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including no external power alarms.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 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: 15128756
• MDR Text Key: 298710791
• Report Number: 2916596-2022-12496
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 813024010883
• 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: Nurse
• Type of Report: Initial
• 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 Model Number: 107754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2022
• Initial Date FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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: 56 YR
• Patient Weight: 61 KG