MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®; Ventricular (assist) bypass

Model Number	1440
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that universal battery charger (ubc) was broken.When the ubc was turned on, all four slots showed red lights, and the telephone icon was on the screen.The patient was issued a new charger this past weekend.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of red light on all four charging slots was confirmed with the returned universal battery charger (serial # (b)(6)).The unit was received at the service center.After the boot up process, an error code was displayed on all four charging slots.Visual inspection revealed fluid ingress issue on the power supply board assembly.The unit was not repaired, and no further evaluation was performed due the extensive amount of fluid ingress issue.A root cause that led to the fluid ingress issue could not be determined.Care and maintenance of the heartmate universal battery charger (ubc) are addressed in the heartmate ii instructions for use (ifu) and the heartmate 3 instructions for use.Under section 3, power the system, description of battery charger pocket lights and their meaning.A green light means the battery is charged and ready for use.A steady yellow light means the battery is actively charging.A red light means the battery is defective or the charger has a problem.See table 3.3 for a complete description of charger pocket light color codes.Under section 8, equipment storage and care, general cleaning guidelines for all equipment use a damp cloth to clean exterior surfaces of the system components, as needed.Water, with or without a mild dish soap, may be used as a surface cleaner.Warning do not allow water to penetrate into the interior of the equipment.Do not immerse equipment in water or liquid.Immersion in water or liquid may cause the pump to stop.Under section f, safety checklists, replace any equipment or system component that appears damaged or worn.Schedule a battery charger inspection and cleaning with thoratec-trained personnel.The safety inspection and cleaning includes (but is not limited to) functional testing, cleaning, and inspection.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE®
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 22063074
• Report Number: 2916596-2025-03455
• Device Sequence Number: 7849981
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: (01)00813024010678(17)240228
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

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: 1440
• Device Catalogue Number: 1440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2025
• 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: 05/20/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White