MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 14 VOLT LITHIUM ION BATTERY SET; VENTRICULAR (ASSIST) BYPASS

Model Number 2465

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of the 14-volt battery displaying a red light status on a universal battery charge (ubc) and having a low runtime were both confirmed.Upon arrival, the returned 14-volt battery (serial number (b)(6)) displayed a red light when placed within a test ubc.The battery also operated alongside a mock loop with a test system controller, and the controller alarmed with a low voltage hazard, indicating that the battery would not be able to provide power for an extended period.The 14-volt battery was opened and inspected at a component level.Electrical measurements revealed that one of the battery¿s components related to its voltage management was damaged.One of the component¿s suspected pins became displaced upon light probing of the component, indicating that the pin may have had a damaged solder joint, and a damaged solder joint on this pin would have caused the reported events to occur.The root cause of the reported events was determined to have been component damage on the battery¿s printed circuit board; however, the root cause of this damage was unable to be conclusively determined.Device history records (dhr) for the 14-volt battery reside with the original equipment manufacturer (oem).However, the 14-volt battery was observed to have passed all initial manufacturing testing per the battery inspection datasheet.The heartmate 3 patient handbook (rev.D) instructs users on how to properly use, charge, and calibrate 14-volt batteries.If a red light status becomes active on the ubc while the battery is charging, users are advised to not use that battery.The patient handbook also instructs users on how to check the current relative charge of the 14-volt batteries.Two batteries are expected to power the system for approximately 17 hours, and this can vary depending on activity level.The heartmate 3 patient handbook (rev.D, 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.

Event Description

It was reported that the patient had 2 batteries giving error messages while in the battery charger and the batteries were replaced.

• Brand Name: HEARTMATE 14 VOLT LITHIUM ION BATTERY SET
• Type of Device: 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: 18998231
• MDR Text Key: 339027356
• Report Number: 2916596-2024-01923
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: 00813024010692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2465
• Device Lot Number: SX116-B181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Sex: Male
• Patient Weight: 70 KG