MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; 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 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date, age of device and device unique identifier (udi) are unknown.The system controller and backup battery were not returned for evaluation (as the system controller remains in use).(the backup battery was reportedly discarded).As the backup battery serial number was not provided, the manufacture date of the backup battery could not be confirmed.Although rechargeable, according to the design, the backup battery has a limited lifespan of 36 months from the manufacture date and a backup battery fault advisory alarm will occur at 12:00am midnight on the first day of the month in which the backup battery reaches its expiration date.Based on the reported event, the system controller would have alarmed with a backup battery fault if the backup battery expiration month was reached.According to the heartmate ii left ventricular assist system instructions for use, the system monitor displays information about the backup battery charge level and the time remaining before its replacement is mandatory.Depending upon a patient¿s clinic schedule, replacement of the 11 volt lithium-ion battery should be considered when less than 6 months remain before the mandatory expiration date.Reports of backup battery fault advisory alarms occurring for heartmate ii system controllers with backup batteries that have reached their limited lifespan of 36 months have been addressed through the manufacturer's corrective/preventative action system, updated device labeling for the monthly safety checklist, and an urgent medical device correction notice (2916596-9/14/15-001-c).No further information was provided.The manufacturer is closing its file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2011.It was reported that the system controller showed a yellow wrench and backup battery fault alarm.The system controller worked otherwise with green arrows illuminated.Patient denied any other alarms.The patient was asymptomatic.Patient presented to clinic and system controller history interrogation revealed system controller backup battery (ebb) had expired.No additional information was provided.

Manufacturer Narrative

Product disposition indicated the system controller is not returning for an evaluation.The reported incident of a backup battery fault alarm was confirmed with the system controller log file.A review of the device history records revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.

• Brand Name: HEARTMATE II LVAS
• 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: 7303800
• MDR Text Key: 101473783
• Report Number: 2916596-2018-00744
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• 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: 04/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 54 YR
• Patient Weight: 75