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

Model Number	1440
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the power cord enclosed with the universal battery charger was stained like burnt.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Section d9: the power cord of the universal battery charger returned for evaluation.Manufacturer¿s investigation conclusion: the reported event of the universal battery charger (ubc) ac power cord being stained was confirmed.Visual inspection of the returned ac power cord revealed a small, dark mark on the connector that plugs into the ubc ac inlet.The ac power cord was functionally tested with a laboratory ubc and was found to function as intended during analysis.A manufacturing analysis was completed to further investigate the reported event.It was determined that the discoloration could have not been detected during packaging and final inspection.The manufacturing procedure was updated to provide more detailed visual inspection steps and an awareness training on the visual inspection process was completed.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 patient handbook (rev.C) section 10 and heartmate 3 instructions for use (ifu) (rev.A) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook (rev.C) section 6 "caring for the equipment" and heartmate 3 instructions for use (ifu) (rev.A) section 8 "equipment storage and care" describe how to care for and clean all equipment.Heartmate 3 patient handbook (rev.C) section 10 and heartmate 3 instructions for use (ifu) (rev.A) section 3 ¿powering the system¿ explain the operation of the ubc, including how to connect the ac power cord.Heartmate 3 patient handbook (rev.C) 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: 18707358
• Report Number: 2916596-2024-00987
• Device Sequence Number: 15583024
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: (01)00813024010678(21)UBC-65194(11)221219
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 1440
• Device Catalogue Number: 1440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG