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

Model Number 107754

Device Problems Electrical Power Problem (2925); Material Deformation (2976); Complete Loss of Power (4015)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient had damage to their mobile power unit (mpu) that caused no external power alarms when connected.Log files captured low voltage hazard events on (b)(6) 2022 while on the mpu.The voltages were reading zero as if the power leads were not connected.The pins in the mpu cable were noted to be very slightly bent.The patient was given a new mpu and the alarms resolved.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of a no external power alarm, and the mpu¿s pins being slightly bent, were not confirmed.However, the reported event of atypical power cable disconnect/low voltage hazard alarms was confirmed via the provided log file.The log file contained data spanning approximately 1 day ((b)(6) 2022 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.Several atypical power cable disconnect/low voltage hazard alarms (rsoc invalid faults that were not associated with a power source exchange) were observed throughout the data while the mpu was in use.The alarms appeared to have been caused by the rsoc within one or both power cable(s) briefly dropping below the alarm threshold(s).No other notable events regarding the mpu were observed.The mpu (serial number (b)(4) was not returned for analysis.The root causes of the reported events were unable to be conclusively determined through this analysis.Review of the device history record for the mobile power unit, serial number (b)(4), showed the device was manufactured in accordance with manufacturing and quality assurance specifications.The heartmate 3 patient handbook (rev.D, section 5 ¿alarms and troubleshooting¿) instructs users on how to resolve alarms that sound from their system controller, including alarms associated with power cable disconnect/low voltage conditions.The heartmate 3 patient handbook (rev.D, section 10 ¿safety checklists¿) instructs users to regularly inspect their equipment, including the mpu, to ensure that no equipment appears damaged.Users are encouraged to replace any damaged equipment.The heartmate 3 patient handbook (rev.D, section titled "emergency contact list") cautions 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.

• 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: 14516575
• MDR Text Key: 292826396
• Report Number: 2916596-2022-11096
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• 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: 05/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 94 KG