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

Model Number	107754
Medical Device Problem Codes	Disconnection (1171); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Event or Problem Description
It was reported that the patient experienced power cable disconnects when connected to the mobile power unit (mpu).The mpu was exchanged.Upon closer inspection, there appears to be bite marks on the patient cable and ac power cord.Pump functioned as intended.It was said no additional information would be provided.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of power cable disconnect alarms on the mobile power unit (mpu) (serial number (b)(6)) was unable to be confirmed through this investigation.The reported event of bite marks on the patient cable and ac power cord was also unable to be confirmed through this investigation.No log file were available for evaluation and the mpu was not returned for further evaluation.No images of the reported damage were submitted.Available information provided that the patient¿s mobile power unit was exchanged and the alarms resolved.The pump was functioning as intended.The root cause of the reported alarms was unable to be conclusively confirmed through this analysis; however, the bite marks on the patient cable could have contributed to the cause of the alarms.The root cause of the bite marks on the patient cable and ac power cord was unable to be conclusively determined through this analysis.The relevant sections of the device history records for the 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 device (lvas) instructions for use (ifu), and the heartmate 3 patient handbook, are currently available.The current revision of ifu and patient handbook can be found on the eifu page of the abbott website.Heartmate 3 patient handbook section 5, entitled ¿alarms and troubleshooting¿, and heartmate 3 instructions for use (ifu) section 7, entitled ¿alarms and troubleshooting¿, cover all alarms (visual and audible), including power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook section 6 ¿caring for the equipment¿ and heartmate 3 instructions for use (ifu) section 8 ¿equipment storage and care¿ explain how to care for and clean all equipment, including the mpu.Heartmate 3 patient handbook section 10 ¿safety checklists¿ and heartmate 3 instructions for use (ifu) section e ¿safety checklists¿ provide the user with checklists to assist the patient in performing routine maintenance of all components of the heartmate 3 left ventricular assist device, including the mpu.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.
Event or Problem Description
It was later reported that exchanging the mpu resolved the alarms.

• 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: 23999744
• Report Number: 2916596-2026-00100
• Device Sequence Number: 10503623
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• UDI-Public: (01)05415067038234(11)250811
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 10964736
• Was Device Available for Evaluation?: No
• 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: 12/17/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2025
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White