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 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device 1 year, 9 months.(calculated from the date when the mobile power unit was issued to the patient).Additional information was requested but was not provided.The mobile power unit remains in use with no further issues reported.A supplemental report will be submitted when the manufacturer's investigation is complete.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported that during a log file review by the technical service representative, no external power/low power hazard events were confirmed on (b)(6) 2018.Additional information has been requested but has not been provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: a full evaluation of the device could not be conducted as the device remains in use.A no external power alarm was confirmed in the review of the submitted log files.A no external power/low battery hazard alarm was captured on (b)(6) 2018 08:07 while the system was powered by an mobile power unit (mpu).The voltage levels indicated that power to the mpu was lost.The pump parameters were not affected during the incidents and the system was supported by the backup battery.The heartmate ii lvas ifu and the heartmate ii patient handbook describe all alarms (visual and audible) and what action should be performed when they do occur.This includes the no external power alarm.A review of the device history records revealed the device met applicable specifications and was manufactured with the v-lock ac connector.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: 8255396
• MDR Text Key: 133334823
• Report Number: 2916596-2019-00094
• 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
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• 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: 03/06/2019
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 125