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

Catalog Number 107754

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2018

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Device serial number was not provided.Therefore, the device information, including age of device, was not available.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 log file review performed by a representative of the manufacturer¿s technical services revealed a no external power/ low power hazard event while the lvad system was supported by the mobile power unit (mpu).This was potentially caused by the power cord of the mpu coming loose at the mpu or the wall outlet.During this event the system controller¿s internal backup battery supplied power to the pump as designed.Additional information was requested, but not provided.

Event Description

It was reported that the no external power/ low power hazard was loss of electricity during a storm.The mobile power unit (mpu) power cord did not come unplugged from the wall outlet or from the mpu.

Manufacturer Narrative

The patient information had been provided.

Manufacturer Narrative

Manufacture's investigation conclusion: the patient remains ongoing and the heartmate mpu remains in use.Evaluation of the submitted log files confirmed a no external power event while the patient was supported by the mobile power unit; however, a specific cause for this event could not be conclusively determined.The controller event log file contained data from (b)(6) 2018 through (b)(6) 2018.The file captured the pump operating at a fixed speed of 5100 rpm with motor power, calculated flow, and average pi typically ranging from 3.206-3.766 watts, 2.5-4.6 lpm, and 2.3-5, respectively.A no external power alarm was captured on (b)(6) 2018 at 7:41:55pm, lasting 35 seconds.This event was preceded by a low power hazard alarm and appeared to be due to a loss of ac power while the system controller was connected to the mobile power unit (mpu).The absence of external power to the system led to the activation of the backup battery (ebb) and there was no interruption in pump function.Despite these alarms, the pump appeared to function as intended, operating above the low speed limit for the duration of the file.The heartmate 3 lvas ifu and patient handbook describe all alarms (visual and audible), including the no external power alarm, and what action should be performed when they do occur.These documents also caution the patients to call their hospital contacts in 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.

• 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: 8017743
• MDR Text Key: 125655337
• Report Number: 2916596-2018-04662
• 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: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR