MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERY CHARGER; VENTRICULAR (ASSIST) BYPASS

Model Number	1440
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
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 presented to clinic on (b)(6) 2024, and the batteries and battery clips had corrosion and were replaced along with the universal battery charger (ubc) due to the ubc also having corrosion.Log files were sent for review, noting several low voltage alarms.Additional information was provided that the alarms resolved with the ubc exchange.Related manufacturer reference number: 2916596-2024-01459 (battery).Related manufacturer reference number: 2916596-2024-01328 (battery).Related manufacturer reference number: 2916596-2024-01329 (battery clip set).
Additional Manufacturer Narrative
Section d4: lot number was requested but was unable to be provided.Manufacturer's investigation conclusion: the reported event of corrosion in one of the universal battery charger (ubc) charging slots was not confirmed.To date, the ubc has not be returned for analysis.Additional information provided communicated that it was not known if or when the ubc would be returned for analysis.This file will be reopened with further analysis if the ubc is returned at a later date.The root cause of the reported event could not be conclusively determined through this analysis.The serial number of the universal battery charger was not reported with the event.Heartmate universal battery charger (ubc) instructions for use provides an overview of how to use and care for the ubc.Section 5 ¿monitoring performance¿ covers all faults, including charger pocket faults, and the actions to take when a fault occurs.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms, including faults that occur on the ubc, and the actions to take if the faults do not resolve.Heartmate 3 patient handbook section 6 ¿ "caring for the equipment" and heartmate 3 instructions for use section 8 ¿ "equipment storage and care" describe how to care for and clean all equipment.Heartmate 3 patient handbook section 10 and heartmate 3 instructions for use 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 universal battery charger (ubc) instructions for use under "warnings" states "keep the universal battery charger (ubc) away from water or moisture.If the ubc has contact with water/moisture, rain/snow, shower spray, or wet surfaces, you may get a serious electric shock or your charger may fail to operate properly¿.The patient handbook and the instructions for use caution 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.

• Brand Name: HEARTMATE UNIVERSAL BATTERY CHARGER
• 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: 18935563
• Report Number: 2916596-2024-01458
• Device Sequence Number: 20593750
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 00813024010678
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/29/2024

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: Lay User/Patient
• Device Model Number: 1440
• 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: 03/05/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 82 YR
• Patient Sex: Male
• Patient Weight: 106 KG
• Patient Race: White