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

Model Number 107754

Device Problems Loose or Intermittent Connection (1371); Loss of Power (1475); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2018

Event Type  malfunction  

Manufacturer Narrative

(serial number) : the serial of the device has been requested, but not yet provided.Approximate age of device - unknown.The patient remains on going with 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 on (b)(6) 2014.It was reported that analysis of a log file submitted to the manufacturer's technical service representative revealed a no external power alarm on (b)(6) 2018, while the vad was connected to a mobile power unit (mpu).This event could have been caused by the ac power cord disconnecting from the back of the mpu, the power cord being disconnected from an outlet, or loss of power to the home.No other unusual events were noted within the log file.Pump and peripheral equipment were functioning as intended.There was no reported adverse impact to the patient due to the event.Additional information received on (b)(6) 2019, stated that the patient denied any loss of power at home for the no external power.The patient was not aware if it came unplugged from the wall or mpu.

Manufacturer Narrative

Although the evaluation of the submitted log files confirmed a no external power event on (b)(6) 2018, a specific cause for this event could not be conclusively determined through this evaluation.The submitted controller event log file captured one no external power event with an associated low voltage hazard alarm on (b)(6) 2018 at 04:30:46 pm while the patient was connected to an mpu.The associated voltage values suggest that the power to the mpu was lost.This event could have been caused by the ac power cord disconnecting from the back of the mpu, the power cord being disconnected from an outlet, or loss of power to the home.The system controller¿s backup battery appeared to properly power the pump during this event.The pump appeared to have functioned as intended above the low speed limit throughout the duration of the log file.The account communicated that the patient denied loss of power at home.The patient did not know if the mpu cord came unplugged from the mpu or the wall outlet as he was unaware that the alarm occurred.Although (b)(4) was manufactured with the v-lock ac power cord, it cannot be determined whether the v-lock cable was in use at the time of the event.The patient remains ongoing and no further issues have been reported at this time.

• 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: 8220455
• MDR Text Key: 132418093
• Report Number: 2916596-2019-00042
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• 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
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: No
• 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: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 78