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

Catalog Number 107754

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900); Power Problem (3010); Complete Loss of Power (4015)

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

Event Date 07/24/2018

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device - 1 year, 8 months (calculated from the estimated date when the device was issued to the patient).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) on (b)(6) 2016.It was reported that interrogation of the patient's lvad system showed a loss of power in the history file.The patient was asymptomatic.Review of the submitted log file by the manufacturer's technical services representative noted that a no external power event, that was potentially was caused by the mobile power unit¿s (mpu) power cord coming loose at the mpu connection or the wall outlet.During the event, the system controller backup battery supplied power to the pump as designed.

Manufacturer Narrative

The mobile power unit (mpu) was not returned for evaluation.A specific root cause of the captured event could not be determined.The account communicated that the patient¿s alarm history showed a loss of power.The patient thought that it might be due to the outlet at home.The patient reportedly looked good and was asymptomatic.It was later reported that the patient checked the wall outlet and no equipment was replaced.The mobile power unit was not returned for evaluation and remained in use.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.

• 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: 7792224
• MDR Text Key: 117446125
• Report Number: 2916596-2018-03127
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• 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: 10/29/2018
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 75