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

Model Number 107758

Device Problem Failure to Power Up (1476)

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

Event Date 05/06/2022

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 mobile power unit (mpu) was damaged as the controller did not detect power on both cables when connected to it.After connecting to a new mpu, the system worked again.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of losses of power on the mobile power unit (mpu) was confirmed via analysis of the submitted log file; however, the issue was not reproduced during testing of the returned mpu (serial number: (b)(6) ).The log file contained approximately 2 days of data ( (b)(6) 2022 ¿ (b)(6) 2022 per the timestamp).Power cable disconnect alarms not associated with power source exchanges activated throughout the log file due to the relative state of charge (rsoc) dropping to approximately 0 v while connected to the mobile power unit (mpu).Low voltage hazard alarms also activated when both power cables were connected to the mpu when the voltage issue occurred.The atypical alarms resolved each time when the rsoc voltages on the mpu returned to the appropriate range or when the power source was exchanged.This issue did not affect the controller¿s ability to support the pump at the set speed.The pump maintained a speed above the low speed limit throughout the log file.The returned mpu was evaluated by european distribution center (edc).The mpu was functionally tested in a mock circulatory loop and no issues were observed.There were no issues observed on the returned mpu that would result in the reported event.The mpu was returned to the rental pool.The root cause of the reported event could not be conclusively determined through this analysis.There were incidental findings of the patient cable rubber encasing being loose due to a gap being observed between the plastic lemo connectors and the rubber housing, minor damage on the battery compartment cover near the locking screw, and a small crack on the bottom housing near the ac outlet.The device history records were reviewed and the records revealed that the mobile power unit, serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The mobile power unit was shipped to the customer on 20jun2021.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including the no external power, power cable disconnect and low voltage hazard alarm conditions, and the actions to take if the alarms cannot be resolved.Furthermore, the subsection ¿what not to do: driveline and cables¿ informs the user to check the system controller and mobile power unit (mpu) power cables for twisting, kinking, or bending which could cause damage to the wires inside.This section informs the user not to twist, kink, or sharply bend the system controller or mpu power cables and to carefully unravel and straighten the cables if they become twisted, kinked, or bent.Heartmate 3 patient handbook and heartmate 3 instructions for use (ifu) section 3, entitled ¿powering the system¿, informs the user to transfer from the mpu to another power source in the event of a power failure.Do not rely on the controller¿s backup battery as a power source as it will only power the pump for a limited amount of time and the pump will stop.Subsection ¿switching power sources¿ explains how to switch from the mpu to batteries.Heartmate 3 instructions for use (ifu) section 8, entitled ¿equipment storage and care¿, and heartmate 3 patient handbook section 6, entitled ¿caring for equipment¿, explain how to properly care for the equipment, including the mpu and the patient cable.Heartmate 3 patient handbook section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvad, including inspecting the mpu and the mpu patient cable for damage.This section also informs the user to replace any equipment or system component that appears damaged or worn.The heartmate 3 patient handbook cautions the user 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: 14523324
• MDR Text Key: 292826109
• Report Number: 2916596-2022-10881
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 07/29/2022

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: 107758
• Device Lot Number: 7792607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 07/28/2022
• Supplement Dates FDA Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2021
• 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
• Patient Weight: 105 KG