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

Model Number 107758

Device Problems Circuit Failure (1089); Electro-Static Discharge (2149); Inappropriate or Unexpected Reset (2959)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

The mobile power unit is not a single use device.Approximate age of the device is 2 years and 3 months (calculated from the manufacture date of the mobile power unit).Device evaluation: the reported event of the mobile power unit was not functioning was confirmed during analysis.The evaluation of the returned mobile power unit revealed compromised/damaged power supply printed circuit board (pcb) components.As a result, the unit was not able to supply power.A specific root cause for the compromised component was not able to be identified during analysis.The company will continue to monitor for similar incidents.A review of the device history records revealed the device met applicable manufacturing specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that during routine maintenance, the device did not start up.After replacing power supply, the problem was solved.There was no patient involvement with the event.No additional information was provided.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: on (b)(6) 2019 abbott decided to recall the mobile power unit (mpu) related to mpu pcba damage caused by an esd event and this esd event also resulted in a hm3 motor reset.Unexpectedly the pump was able to restart and run on the backup battery.The mechanism of how the pump was able to restart is being investigated by capa per internal procedures.

• Brand Name: HEARTMATE MOBILE POWER UNIT, EU
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8172377
• MDR Text Key: 130641365
• Report Number: 2916596-2018-05401
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 107758
• Device Catalogue Number: 107758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q419-MCS-2
• Patient Sequence Number: 1