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

Model Number 107754

Device Problems Use of Device Problem (1670); Manufacturing, Packaging or Shipping Problem (2975); Insufficient Information (3190)

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

Event Date 04/03/2021

Event Type  malfunction  

Event Description

It was reported that the patient's mpu was alarming all three lights illuminated on the display.The patient brought in the mpu and plugged in the mpu with the same results.Per the vad coordinator the internal aa batteries are brand new.The patient was given a loaner.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the mpu alarming with all three lights illuminated was not confirmed.The returned mpu (serial number: (b)(6)) was received at the service depot without its original aa batteries and ac power cord; three new aa batteries and a new v-lock power cord were provided.The mpu was powered on while connected to a test hm3 controller and mock loop.The mpu operated as intended throughout several days of testing, even when the ac power cord was manipulated by hand, and atypical events were unable to be reproduced.A full functional checkout was performed, and the serviced and tested mpu was converted to a rental unit after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.The heartmate 3 patient handbook describes all alarms (visual and audible) and what action should be performed when they do occur, including the alarms related to the mpu.The heartmate 3 patient handbook cautions 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.Review of the device history record for the mobile power unit, serial number: (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section h6 medical device problem code: correction."3190 - insufficient information" and "2975 - manufacturing, packaging or shipping problem" removed.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: 11754264
• MDR Text Key: 264333096
• Report Number: 2916596-2021-01946
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2021
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 63 KG