MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; LVAD SYSTEM CONTROLLER

Catalog Number 106762

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approximate age of device- 5 years and 1 month.The patient remains ongoing with the lvad device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on 2(b)(6) 2013.It was reported that the manufacturer¿s technical services representative reviewed the submitted log file and reported that the file captured that the system controller backup battery passed expiration date.The remainder of the log file was unremarkable.

Manufacturer Narrative

Additional information the reported event of a backup battery fault alarm was confirmed during the analysis of the submitted system controller log file.The system controller was not returned for evaluation and remains in use.The system controller activated a backup battery fault advisory alarm as designed.It should be noted that the battery expiration did not affect its primary function to provide power to the system.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that the hospital did replace the expired ebb and will not be returning it.The patient was placed on an ungrounded cable.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: LVAD SYSTEM CONTROLLER
• 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 ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7489912
• MDR Text Key: 108094470
• Report Number: 2916596-2018-01660
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 106762
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 62