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

Model Number 107758

Device Problem Unexpected Shutdown (4019)

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

Event Date 07/05/2022

Event Type  malfunction  

Event Description

It was reported that the patient woke up in the middle of the night due to a loud bang from the mobile power unit (mpu) which was followed by no external power hazard alarms.The external backup battery began to power the lvad, and the lvad was running as expected.The patient was doing fine, and switched directly from the mpu to batteries, which resolved the alarm.The mpu was still connected to ac power but no functional led was lighting up anymore.The patient visited the outpatient clinic in the morning, and a review of the log files confirmed the no external power hazard alarms.There were no further issues with the lvad device or system controller.The mpu was connected to ac power again but the device did not turn on, there were no self test beep sounds, and the led did not light up.The patient was given a new mpu.

Manufacturer Narrative

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

Event Description

Additional information was received that the mpu was confirmed to have a v-lock connector, and there had been no interruptions to ac power that may have contributed to the event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a no external power alarm was confirmed.The mobile power unit (mpu) (serial number: (b)(6) ) was returned for analysis, and a log file ((b)(5)) was submitted for review that showed events spanning approximately 5 days ((b)(6) 2022 per timestamp).A loss of external power event that was associated with low power hazard, power cable disconnect and no external power alarms were active on 05jul2022 from 00:36:14 ¿ 00:38:32.The no external power alarm activated due the voltage across both cables simultaneously decreasing to ~0.0v in approximately 5 seconds.The backup battery provided power to the system during these events.The alarm cleared when power was restored to the controller.Pump operation was not affected.There were no other notable alarms.The mobile power unit (mpu) (serial number: (b)(6) ) was returned for analysis to the european distribution center (edc) and was evaluated on 29jul2022.The unit was found to be in good condition; however, was unable to be booted up due to a blown fuse.No functional testing was performed due to the device not powering on.The power supply printed circuit board (pcb) was replaced, and all testing was performed as per procedure.The replaced power supply pcb was forwarded to the product performance engineering (ppe) lab for further analysis.The pcb was tested further in the ppe lab.The returned pcb was inserted into a functioning test mpu.The unit was plugged in but did not power on.Circuit analysis was performed, and it was found that no voltage was being output from the fuse (f1).The fuse was replaced and the mpu was able to operate as intended.A root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed and the records revealed the mobile power unit (serial number: (b)(6) ) was manufactured in accordance with manufacturing and qa specifications.Heartmate 3 instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.Additionally, heartmate 3 patient handbook section 10 entitled ¿safety checklists¿, instructs users to regularly inspect their accessories for damage, and to replace any equipment that appears damaged or worn.Heartmate 3 instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including no external power alarms.Heartmate 3 instructions for use section 3 ¿ ¿powering the system¿ and heartmate 3 patient handbook section 3 ¿ ¿powering the system¿ addresses the user to not use expired batteries and advises the user to properly dispose of them.Heartmate 3 patient handbook and heartmate 3 instructions for use (ifu) caution 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, EU
• 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: 15094458
• MDR Text Key: 304539614
• Report Number: 2916596-2022-12126
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 107758
• Device Lot Number: 8264558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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 Sex: Male