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

Model Number 107754

Device Problems Loss of Power (1475); Complete Loss of Power (4015)

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

Event Date 05/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient¿s log file captured a no external power event on (b)(6) 2021 that was caused by power to the mobile power unit (mpu) being briefly interrupted when the patient reported they lost power to their house.They switched from mpu to batteries till power was restored.No additional information provided.

Manufacturer Narrative

Section d4: serial number was requested but not provided.Section d6a: implant date inadvertently reported in previous report and is not applicable for this device.Manufacturer's investigation conclusion: the reported event of no external power alarm was confirmed via the log file review.The log file spanned approximately 18 days (06may2021 to 24may2021 per the timestamp).A no external power alarm was observed on 19may2021 at 19:31 due to rsoc and bus voltage diminishing to ~0v while the device was connected to mobile power unit.The backup battery was able to provide power to the pump during the alarm.The alarm resolved shortly after reconnecting to a power source.No other notable alarm was observed.The mobile power unit was not returned for analysis.Multiple attempts were made to obtain additional information regarding the event; however, no response was received.A root cause of the reported event was determined to be power outage at the patient¿s house.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 iii instructions for use (rev.A) section 7-¿alarms and troubleshooting¿ and heartmate iii patient handbook (rev.C) section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including no external power.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: 12041384
• MDR Text Key: 257571789
• Report Number: 2916596-2021-03021
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• 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: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 98