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

Model Number 107754

Device Problem Electrical Power Problem (2925)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

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

It was reported that the patient had a low voltage alarm while on mobile power unit (mpu) power.The patient's mpu cables and o-rings were inspected but no issues were observed.On (b)(6) 2020, the mpu had a biomedical engineering (bme) check with no issues identified, either.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a low voltage advisory while connected to the mobile power unit (mpu) was not confirmed.The mobile power unit (mpu) was not returned for analysis; however, a log file was submitted for review with events spanning approximately 2 days ((b)(6)2020 per timestamp).There were no notable alarms active in the log file.Additional information received on (b)(6) 2020 stated that the customer confirmed the patient was on the mobile power unit (mpu) at the time of the reported low voltage advisory alarm.A root cause for the reported low voltage advisory alarms was unable to be conclusively determined through this analysis.Heartmate 3 patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the low voltage advisory alarm conditions, and the actions to take if the alarms cannot be resolved heartmate 3 instructions for use (ifu) under section 3 ¿powering the system¿ explains the various ways to power the heartmate 3 lvas, including how to use the mpu.This section also informs the user to transfer from the mpu to another power source in the event of a power failure.Heartmate 3 patient handbook and heartmate 3 instructions for use (ifu) caution 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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11083025
• MDR Text Key: 225768622
• Report Number: 2916596-2020-06190
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1