MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE-CTRL BTT-11V LI-ION; HEARTMATE-CTRL 11V LI-ION BATTERY

Catalog Number 106128

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

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

Event Date 11/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The serial number was requested but was not provided.The battery is expected to be returned for evaluation.It has not yet been received.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 on (b)(6) 2014.It was reported that a backup battery alarm occurred.It was reported that the system controller backup battery was past its expiration date.No further information was provided.

Manufacturer Narrative

The system controller and backup battery were not returned for evaluation.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.The submitted system controller log file contained data from (b)(6) 2016 to (b)(6) 2017 according to the timestamp.On (b)(6) 2016 the system controller was disconnected and powered down.The system controller was reconnected to an lvad and external power on (b)(6) 2017 and supported the pump at the set speed.However, the system controller alarmed with a backup battery fault alarm per design due to the internal backup battery being past its expiration date.This alarm did not affect the system controller's ability to support the pump at the set speed, but remained active until the end of the log file.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.

• Brand Name: HEARTMATE-CTRL BTT-11V LI-ION
• Type of Device: HEARTMATE-CTRL 11V LI-ION BATTERY
• 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: 7082597
• MDR Text Key: 94236242
• Report Number: 2916596-2017-03036
• 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: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 106128
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2018
• 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
• Removal/Correction Number: 2916596-9/14/15-001-C
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 77