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 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Device serial number was not provided.Therefore, the expiration date, age of device, and manufacture date are unknown.(b)(4).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).It was reported that during review of the submitted system controller log file by a representative of the manufacturer¿s technical services, a backup battery fault alarm was observed as having occurred on (b)(6) 2018.The timestamp indicated that the alarm was due to the internal backup battery exceeding its expiration date.A yellow wrench alarm occurred on (b)(6) 2018 at 12:00:51 am, indicating backup battery fault alarm with the system controller error code of backup battery passed expiration date.The lvad clinician reported that the system controller backup battery was replaced at another facility.

• 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: 7420267
• MDR Text Key: 105440476
• Report Number: 2916596-2018-01294
• 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
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 96