MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA; VENTRICULAR (ASSISST) BYPASS

Model Number 107754

Device Problem Complete Loss of Power (4015)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/26/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient's log files were sent for analysis.Upon review of the log files, technical services noted no external power events on (b)(6) 2020.These were caused by the power to the mpu being briefly interrupted.

Manufacturer Narrative

Section d4: serial number was requested but not provided.Manufacturer's investigation conclusion: the event, of loss of external power while using the mobile power unit (mpu), was confirmed in the submitted log file.The customer submitted heartmate 3 left ventricular assist system (lvas) log files for review ¿ no specific issue was noted.Technical service reviewed the log file and noted a loss of external power event.The event log file contained approximately 3 days of patient event data.There was one loss of external power event that occurred with the patient on the mpu; the events lasted 15 seconds in duration.The controller operated on backup battery power during the event.The mpu was the power source before and after the events.The battery capacity (rsoc) indicators and cable voltages corresponded to a loss of ac power to the mpu.The patient reported that the mpu ac power cord came out of the ac outlet during ambulation resulting in the loss of ac power to the mpu.No product was returned for evaluation.Set up and use of the mobile power unit (mpu) with the heartmate 3 system are documented in the heartmate 3 lvas patient handbook and the heartmate 3 lvas instructions for use (ifu).Alarms and the proper actions to be taken if alarms cannot be resolved are documented in the heartmate 3 lvas patient handbook and the heartmate 3 lvas ifu.Specific warnings and cautions regarding the mpu's set up, the potential tripping hazards presented by the mpu patient cable and power cord, and the electrical outlet used (including location and accessibility) are given in both the heartmate 3 lvas patient handbook and the heartmate 3 lvas ifu.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11180185
• MDR Text Key: 227563342
• Report Number: 2916596-2020-06560
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 106