MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA

Model Number 107754

Device Problems Connection Problem (2900); Power Problem (3010)

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

Event Date 03/29/2018

Event Type  malfunction  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr report # 2916596-2018-01564.This report is being submitted as additional information.The serial number of the device was not provided, therefore the approximate age of device and manufacture date are not known.Corrected information manufacturer's investigation conclusion: the no external power alarms were confirmed based on review of the submitted controller log file.A power cable disconnect alarm was captured on (b)(6) 2018 23:02:16 and 2 seconds later, the ebb in use became active.The rsoc levels dropped from the expected 12 volts to 0 in approximately 5 seconds, activating the no external power alarms.All alarms cleared on (b)(6) 2018 23:02:30.This series of events appeared to be consistent with a loss of ac power while the controller was connected to an mpu.A similar set of events began to occur on (b)(6) 2018 23:24:00 and all alarms cleared at 23:24:09.The system controller's backup battery powered the pump during the power cable disconnect and no external power events.No other atypical alarms were recorded in the remaining events and the pump operated at the set speed throughout the log file.The heartmate 3 patient handbook explains how to use the mobile power unit.Connecting the power cord is also described in this section.The document referenced above warns the user to ¿avoid positioning the mobile power unit where access to the power cord plug into the wall socket is limited or where disconnection of the plug from the wall socket is difficult.If there is a power failure, transfer from the mobile power unit to another power source.The backup battery in the system controller will temporarily power the pump while you transfer to batteries.Do not rely on the controller¿s backup battery as a power source during ac power failure, as it will only power the pump for a limited amount of time and the pump will stop¿.The heartmate 3 left ventricular assist system instructions for use and the heartmate 3 patient handbook caution the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2018.It was reported that the customer submitted log files for review.During the analysis of the log file, the manufacturer's technical service representative observed a no external power alarm.This could be caused by the patient disconnecting from the mobile power unit (mpu) then plugging back into it, or the mpu came unplugged from the wall outlet.There were no other unusual events seen within the log files.No additional information was provided.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Type of Device: MOBILE POWER UNIT
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8206644
• MDR Text Key: 131929223
• Report Number: 2916596-2018-05799
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2018
• 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: 72 YR
• Patient Weight: 65