MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERY CHARGER; 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	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the universal battery charger unit sparked and popped when plugged in and caused a noticeable electrical burning smell.It was noted that the unit wouldn't power on anymore.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the universal battery charger (ubc) being damaged, causing it to no longer power on, was confirmed.The returned ubc (serial number (b)(6)) was functionally tested at the service depot and at the product performance engineering (ppe) department.The unit was able to power on during service depot testing with an active error code on slot 3; however, the unit did not power on throughout all testing at the ppe department.The unit was opened and inspected at a component level, and fluid damage was observed on the unit¿s main printed circuit board, including components associated with slot 3.The root cause of the reported event was determined to be fluid damage within the ubc, as this damage would have caused the reported event to occur; however, the root cause of how the fluid entered the unit was unable to be conclusively determined.Review of the device history record for the ubc, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and 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¿) instructs 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 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: 18522017
• Report Number: 2916596-2023-09003
• Device Sequence Number: 6751448
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 00813024010678
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 03/27/2024

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?: 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: 12/27/2023
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 75 KG