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

Model Number 107754

Device Problems Alarm Not Visible (1022); Display or Visual Feedback Problem (1184); Failure to Power Up (1476); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient got up to use the bathroom around 3:30 am and tripped on their mobile power unit (mpu) cord.Their controller began alarming "controller fault" with the yellow wrench illuminated.The controller indicated the pump was still running.The patient presented to the hospital where a controller exchange was performed.The alarm resolved after controller exchange.The patient's mobile power unit (mpu) also stopped working after this incident.There were no lights or sounds.The aa batteries were checked and were working but nothing happened when it was plugged in.The mpu was exchanged.Log files confirmed a controller internal fault event associated with a low internal system voltage.Controller mfr # 2916596-2023-05251.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a no external power alarm and the mobile power unit (mpu) not powering on was confirmed via the submitted log files and reproduced.A review of the controller event log files spanned approximately 5 days ((b)(6) 2023, and (b)(6) 2023 per time stamp).On (b)(6) 2023 at 03:41:33 while connected to the mpu, the no external power alarm activated while connected to the mpu due to both white and black lead voltages diminishing to 0v.This was consistent with a loss of ac power.The no external power alarm cleared a minute later after switching to batteries.The alarm did not affect the controller's ability to operate the pump at the set speed.There were no other notable alarms active in the log file.During the evaluation of the returned mpu, serial (b)(6), the reported event was confirmed.The unit was plugged into an ac power source and the unit did not power on.The issue was isolated to the power supply pcb which was replaced.A functional test was performed, and all tests passed.The unit was returned to the customer site and is ready for use.Visual inspection of the power supply pcb revealed no anomalies.The pcb was plugged into a test unit and there was no voltage output coming out of the secondary side of transformer t1.Due to the voltage drop, the board did not output the 15vdc required to power the main pcb.Additional information provided indicated that the alarms activated after the patient had tripped on his mpu cord.Once the controller was exchanged, the alarm condition resolved.Per the additional information, the root cause of the reported no external power alarm was due to disconnecting the ac power cord from the wall.The root cause for the mpu not powering on was determined to be a damaged transformer in the power supply pcb; however, a root cause for this damage could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The patient handbook 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.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the controller fault and no external power alarms, and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook section 6 ¿caring for the equipment¿ and heartmate 3 instructions for use (ifu) section 8 ¿equipment storage and care¿ explain how to care for and clean all equipment, including the mpu.Heartmate 3 patient handbook (rev.D) section 10 ¿safety checklists¿ and heartmate 3 instructions for use (ifu) section e ¿safety checklists¿ provide the user with checklists to assist the patient in performing routine maintenance of all components of the heartmate 3 left ventricular assist device, including the mpu.Heartmate 3 instructions for use section 8-¿equipment storage and care¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly handle the equipment to prevent damage.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 (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17392680
• MDR Text Key: 319784630
• Report Number: 2916596-2023-05252
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Lot Number: 8872441
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 119 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American