MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, MOBILE POWER UNIT, N/A; VENTRICULAR (ASSIST) BYPASS

Model Number	107754
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient experienced a yellow wrench alarm on the mobile power unit (mpu).The mpu was exchanged.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of yellow wrench alarm on the mobile power unit (mpu) was not confirmed as no log file was submitted for review and the alarm was not reproduced during evaluation of the unit.The returned mpu (serial number (b)(6)) was serviced at abbott pleasanton and was observed to have kinks within the patient cable and several cuts on the external jacket of the patient cable.The mpu was functionally tested and was found to perform as intended despite the observed damage.The reported issue of a yellow wrench was not reproduced during testing.However, kinked and cut patient cable could have caused the reported yellow wrench alarm.Provided information indicated the patient declined repair quote.The mpu was returned to the customer in unrepaired condition labelled "not for human use" due to damaged patient cable.The root cause of the observed damage was unable to be conclusively determined through this analysis.The relevant sections of the device history records for mobile power unit, serial number: (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) rev.D and the heartmate 3 patient handbook rev.A are currently available.The current revision of the ifu can be found on the eifu page of the abbott website.The heartmate 3 left ventricular assist system (lvas) ifu section 8, entitled ¿equipment storage and care¿ and the heartmate 3 patient handbook section 6 entitled ¿equipment maintenance¿ explain how to properly care for the equipment, including the mobile power unit (mpu) and the patient cable.The heartmate 3 patient handbook section c, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate 3 lvas, including inspecting the mpu and the mpu patient cable connectors 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 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, N/A
• Common Device Name: 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23874170
• Report Number: 2916596-2025-08217
• Device Sequence Number: 10469866
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• UDI-Public: (01)05415067038234(11)250709
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

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
• Operator of Device: Health Professional
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Device Lot Number: 10935712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American