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

Model Number 107754

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported no external power alarms were confirmed via the submitted log files.The mobile power unit (mpu) was not returned for analysis; however, a log file was submitted for review.The log file spanned approximately 25 days (03jun2020 ¿ 29jun2020 per timestamp).On (b)(6) 2020 at 01:13:20 to 01:13:35 a no external power alarm was flagged as active.The alarms activate while the controller is connected to the mpu and appears to be related to a loss of ac power.The backup batter provided power to the to the system during this event.The alarms clear when power is restored to the controller.These alarms cleared shortly after and did not affect pump operation.There were no other notable alarms.Attempts were made to gather more information regarding: the serial number of the mobile power unit (mpu), if the mpu will be returning, if the mpu is currently operational, if the mpu has a v-lock connector on the a/c power cord, and if the power cord came loose at the wall/outlet or if any environmental factors affected the a/c power at the time of the event.To date, no response has been received.The root cause for the no external power alarm while the controller was connected to the mpu was not conclusively determined but appears to be related to a loss of ac power.A device history record review could not be performed due to a serial number not being provided.Heartmate iii patient handbook, under section 5 ¿alarms and troubleshooting¿ and heartmate iii instructions for use (ifu), under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the low voltage and no external power alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate iii instructions for use (ifu) under section 3 ¿powering the system¿ explains the various ways to power the heartmate iii lvas, including how to use the mpu.This section also informs the user to transfer from the mpu to another power source in the event of a power failure.Heartmate iii patient handbook and heartmate iii 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.

Event Description

Log file analysis showed a no external power event on (b)(6) 2020 when the power to the mpu was disconnected.There was also an external backup battery fault seen in the log file.There were no other abnormal alarms or events in the log file.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Type of Device: VENTRICULAR (ASSISST) 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: 10823326
• MDR Text Key: 216370457
• Report Number: 2916596-2020-05253
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 120