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 05/01/2016

Event Type  malfunction  

Manufacturer Narrative

This medwatch report for the primary system controller references the backup battery fault.The patient¿s attempted exchange to the backup system controller and subsequent expiration is reported under medwatch mfr report # 2916596-2016-01025.Device unique identifier (udi) ¿ device was manufactured prior to the udi labeling implementation.Approximate age of device - 3 years (calculated from the date of manufacture of the backup battery).The device was returned for investigation.The evaluation is not yet complete.It was reported that the patient¿s backup battery on both the primary and backup system controllers had been exchanged during a clinic visit on (b)(6) 2015.The backup battery serial number for the primary system controller had not been updated in hospital records and thus the hospital was reportedly unaware the backup battery was due to expire.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.It was reported that the patient experienced a backup battery fault alarm at home and attempted to exchange to their backup system controller.Review of the log file from the backup system controller by the manufacturer's technical services representative revealed the driveline was first connected at (b)(6) 2016 18:16.The pump speed reached 1480 rpm before the driveline was disconnected within the same minute.The driveline was reconnected and disconnected within the same minute three additional times, at (b)(6) 2016 21:10, (b)(6) 2016 22:02, and (b)(6) 2016 02:45.The speed never increased above 1630 rpm.External batteries were disconnected at (b)(6) 2016 12:35 and the last event recorded prior to loss of all power to the system controller was at (b)(6) 2016 19:31.It was reported that the patient passed out and ultimately expired.No further information was provided.

Manufacturer Narrative

The evaluation of the returned backup battery revealed that the backup battery was manufactured on may 2013.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 12:00 am midnight on the first day of the month in which the backup battery reaches its expiration date.Per design, on (b)(6) 2016, the system controller log file displayed a backup battery fault alarm at 12:00 am midnight.The returned backup battery and system controller were connected to test equipment.The returned system controller was powered on and the backup battery fault advisory alarm was displayed.The system monitor displayed the backup battery's manufacture date and indicated the battery life was at 0 months.When external power was removed from the returned system controller, the system continued to operate supported by the returned backup battery.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).Based on the evaluation, the system performed as designed.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.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 651756-407
• MDR Report Key: 5691747
• MDR Text Key: 46304892
• Report Number: 2916596-2016-01024
• 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: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: 2916596-9/14/15-001-C
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 105