MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®; VENTRICULAR (ASSIST) BYPASS

Model Number	1440
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the universal battery charger (ubc) was plugged into the wall, there was a loud pop and it started smoking.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a loud ¿pop¿ and smoking, once the universal battery charger (ubc) was plugged into a wall outlet, was confirmed via evaluation at the service depot.The returned heartmate universal battery charger (serial number (b)(6)) was connected to alternating current (ac) power and switched ¿on¿.The unit did not power on as intended, confirming the complaint.The issue was traced to the power supply printed circuit board assembly (pcba) and charging pocket assemblies.Visual inspection revealed multiple areas of fluid ingress damage, smoke residue, and a blown fuse.The customer declined the repair and authorized to scrap the ubc.The root cause for the reported event was determined to be due to fluid ingress within the ubc; however, a root cause for the fluid ingress was unable to be determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The heartmate 3 patient handbook section 3 ¿powering the system¿ instructs the user to keep the universal battery charger away from liquid at all times.Fluid ingress within the battery charger may cause issues in operations or may cause an electric shock.The heartmate universal battery charger ifu sections ¿warnings and cautions¿ and 6.0 ¿routine inspection and cleaning¿ instruct users to never allow liquid to enter the interior of devices, and to keep the ubc away from liquid as much as possible.The heartmate 3 patient handbook 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®
• 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: 20800492
• Report Number: 2916596-2024-07547
• Device Sequence Number: 6833042
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: (01)00813024010678(11)240320
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 04/21/2025

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
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 118 KG