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

Catalog Number	107754
Medical Device Problem Codes	Connection Problem (2900); Power Problem (3010)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the device was requested but was not provided; therefore, the expiration date, manufacture date, and age of device are unknown.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.
Event or Problem Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016.It was reported that when the patient was seen at the clinic, a no external power alarm was observed in the history file upon interrogation of the lvad system.The patient did not recall the incident occurring.There was no adverse impact to the patient reported.A log file submitted to the manufacturer¿s technical services for analysis confirmed a no external power event recorded on (b)(6) 2018.This could be caused by the power cord of the mobile power unit (mpu) coming loose at the mpu or the wall outlet.During these events the system controller¿s internal backup battery provided power to the pump as designed.Additional information was requested, but not provided.
Additional Manufacturer Narrative
Manufactures investigation conclusion: the mobile power unit (mpu) was not returned for analysis and remains in use.Evaluation of the submitted log files confirmed no external power alarms while the patient was supported by the mobile power unit; however, a specific cause for this finding and a direct correlation to the patient¿s mpu could not be conclusively established.The submitted log file showed that the no external power alarm appeared to be caused by a loss of ac power while the system controller was connected to the mpu.No additional atypical alarms or trends in pump parameters were captured.The fixed speed was set to 9000 rpm and the pump speed remained above the low speed limit of 8400 rpm for the duration of the file, including the no external power event.Multiple requests for additional information were sent to the account; however, no further details were provided.The hmii patient handbook addresses all alarm conditions (including no external power alarms) and cautions 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.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Common Device Name: MOBILE POWER UNIT
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7793157
• Report Number: 2916596-2018-03470
• Device Sequence Number: 13738946
• Product Code: DSQ
• UDI-Device Identifier: 00813024013006
• UDI-Public: 00813024013006
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 12/07/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 59