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

Model Number 107754

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device- 1 year and 2 months.The patient remains ongoing with the lvad device.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) 2018.It was reported that the patient presented with no external power alarms times 2 on (b)(6) 2019 at 0600.The patient reported accidentally unplugging the mobile power unit (mpu) while ambulating.Log file submitted captured a no external power event on (b)(6) 2019 that was caused by the power to the mpu being briefly interrupted.Additional information was requested but not provided.

Manufacturer Narrative

Section d4: multiple attempts were made to retrieve device serial number but this information was not provided.Section h4: device manufacture date cannot be extracted due to the account not providing a device serial number.Manufacturer's investigation conclusion: the investigation confirmed the reported no external power alarms via the submitted log file.The log file contained approximately one day of data (b)(6) 2019 ¿ (b)(6) 2019 per timestamp).On (b)(6) 2019 at 6:08, the voltage across both cables simultaneously dropped to ~6.5v then to ~0v in approximately 4 seconds activating the low power hazard and no external power alarms.The alarm cleared once power was restored, the event lasted approximately 23 seconds, and appear to be related to a loss of power while connected to the mpu.The alarms did not affect the controller¿s ability to operate the pump at the set speed.The mobile power unit was not returned for analysis and remains in use.The provided information indicated that the patient accidentally unplugged himself from the unit while ambulating.The root cause for the reported event was determined to be user error in the patient unplugging himself from the unit.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: 8979213
• MDR Text Key: 159021674
• Report Number: 2916596-2019-04074
• 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
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• 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: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 97