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

Catalog Number 106762

Device Problems No Audible Alarm (1019); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

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

Event Date 01/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 2 years and 3 months (calculated from the date when the system controller was issued to the patient.) the event occurred at (b)(6).The patient remains ongoing on lvad support.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 (b)(6) 2015.It was reported that the system controller backup battery expired on (b)(6) 2018 and triggered a backup battery fault alarm.In addition, power cable disconnect and low flow alarms were noted that could not be heard due to the ongoing backup battery alarm.The patient went to the clinic to have the backup battery replaced.The patient remained asymptomatic.After installation of the new backup battery, the alarms resolved.No further issues have been reported.

Manufacturer Narrative

The reported event of low flow, power cable disconnect and backup battery fault alarms was not able to be determined.The system controller was not returned for evaluation and remained in use.The reported event of a backup battery fault alarm due to expired battery was not able to be determined.The backup battery serial number was not returned for evaluation.According to the additional information the backup battery will not be returned, the clinic has disposed it before reporting this event.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: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7355283
• MDR Text Key: 103275432
• Report Number: 2916596-2018-01033
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• 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?: No
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2015
• 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: 59 YR
• Patient Weight: 63