MAUDE Adverse Event Report: Thoratec Corporation HEARTMATE®, MOBILE POWER UNIT, N/A; Ventricular (Assist) Bypass

Model Number	107754
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mobile power unit (mpu) patient cord fell into water, and the clinic advised the device should not be used.A warranty replacement was requested.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the heartmate mobile power unit (mpu) patient cable being dropped into water was not confirmed.The returned mpu, serial number (b)(6), was visually inspected at the service depot and product performance engineering (ppe) department and no signs of fluid ingress were observed in the mpu or mpu patient cable connectors.The unit was connected to ac power and the unit booted up as intended.The unit was authorized to be scrapped by the customer.Although the fluid ingress was not confirmed, per provided information, the root cause of the fluid ingress was determined to be user error.Incidental findings: damage to the black power cable connector threads.The device history records were reviewed and the records reveal that the heartmate mobile power unit (mpu), serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The current revision of the instructions for use (ifu) and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu, rev.D, heartmate 3 patient handbook, rev.A are currently available.Section 8 of the ifu, entitled ¿equipment storage and care¿, provides instruction on how to care for and clean all equipment, including the mobile power unit (mpu).Section f of the ifu, entitled ¿safety checklists¿, instructs the user to perform routine maintenance on all the equipment, including the mpu and patient cable.Section 2 of the ifu, entitled ¿system operations¿, warns if the external system components contact water or other moisture, the pump may stop.Section 6 of the ifu, entitled "patient care and management", instructs the user to never expose the mpu to water.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.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 ; +1(781)852-8207
• MDR Report Key: 50948278
• Report Number: 2916596-2026-2920229
• Device Sequence Number: 9534703
• Product Code: DSQ
• UDI-Device Identifier: 05415067038234
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Device Lot Number: 11144534
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/05/2026
• 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: 09/29/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2025
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 235 LB
• Patient Race: Black Or African American