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

Model Number 107754

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device - 1 year and 3 months.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported the log file captured a no external power event on (b)(6) 2019.There was no interruption in pump support to the patient during the no external power events.

Manufacturer Narrative

Section a2, a3, a4, d4: multiple attempts to obtain patient and device information were made, but no response was received.Section b1: correction.Section d4, d5, h8: additional information.Manufacturer's investigation conclusion: the reported no external power events while patient was on the mobile power unit [mpu] were confirmed via the provided log file.The log file contained 240 events spanning a period of ~37 days (b)(6) 2018 at 11:17:36 ¿ (b)(6) 2019 at 16:53:47 per time stamp].On (b)(6) 2019 at 07:28:30, (b)(6) 2019 at 06:07:44, and (b)(6) 2019 at 02:46:49, the rsoc dropped below 5v in ~5 seconds activating the low power hazard and no external power alarms.The no external power alarm appeared to be caused by a loss of ac power while the controller was connected to the mpu.The no external power alarm did not affect the controller¿s ability to operate the pump at the set speed.There were no other notable alarms active in the log file.The mobile power unit was not returned for analysis.Attempts were made to get more information regarding the cause of no external power, no further information was provided.A root cause for the loss of ac power was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Type of Device: MOBILE POWER UNIT
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8352879
• MDR Text Key: 136605738
• Report Number: 2916596-2019-00771
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention