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

Model Number 107754

Device Problem No Apparent Adverse Event (3189)

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

Event Date 04/18/2022

Event Type  malfunction  

Event Description

Related mfr#s: 2916596-2022-10516, 2916596-2022-10517, 2916596-2022-10837, and 2916596-2022-10836.It was reported that on (b)(6) 2022 the patient performed an emergent system controller exchange due to a yellow wrench alarm.On (b)(6) 2022, the patient's new primary system controller alarmed for driveline power faults and power cable disconnects.There were also low flow alarms, no external power alarms, driveline disconnect alarms, and pump off alarms.The system controller was exchanged again on (b)(6) 2022 due to yellow wrench and red heart alarms.Later that day, an emergency medical technician (emt) was called to the patient's home where they found the door on the back of the controller that covers the driveline eject button was unable to completely close.This indicated that the driveline was not completely seated into the controller.The emt plugged the controller all the way in and then closed the door and locked it in place.The display showed the pump speed to be of 5400 rpms.The patient was then transported to the hospital where they passed away.The mobile power unit (mpu) was returned to the manufacturer following the patient's death.

Manufacturer Narrative

Related mfr#: 2916596-2022-10516 reports on the patient's pump and covers that patient's death.Related mfr# 2916596-2022-10517 reports on the first system controller exchange that occurred on (b)(6) 2022.Related mfr# 2916596-2022-10836 reports on the second system controller exchange that occurred on (b)(6) 2022.Related mfr# 2916596-2022-10837 reports on the third system controller that the emt noted the driveline was not fully plugged into.Manufacturer's investigation conclusion: the mpu (serial #: (b)(4) was returned for evaluation to the service depot following a patient death.The mpu was connected to a test loop and run for several days.The unit passed the functional checkout and functioned as intended.The reported alarms were not confirmed.The reported event could not be correlated to an issue with the returned mpu.Incidental findings: patient cable loose at lemo connector.The device history records were reviewed for the mpu and the mpu was found to pass all manufacturing and qa specifications before being shipped to the customer on 25 may 2018 via customer order.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.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.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: 15122507
• MDR Text Key: 304715532
• Report Number: 2916596-2022-12547
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• 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
• Report Date: 07/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2018
• 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: 80 YR
• Patient Sex: Male
• Patient Weight: 89 KG