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

Model Number 2465

Device Problem Leak/Splash (1354)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the battery was leaking battery acid onto the metal prongs of the battery, preventing it from working properly.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the 14-volt battery leaking was confirmed via damage observed on its contacts upon arrival; however, the reported event of the battery not functioning properly was not confirmed.The returned 14-volt battery (serial number (b)(6)) was observed to have fluid damage/corrosion on most of its contacts upon arrival correlating to the reported leak.The 14-volt battery was functionally tested alongside known working test equipment and was found to perform as intended despite the observed damage.No log files were associated with the reported event.The root cause of the reported event was unable to be conclusively determined through this analysis.Device history records (dhr) reside with the original equipment manufacturer (oem).However, the battery was observed to have passed all initial manufacturing tests per the greatbatch manufacturing 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 10 ¿safety checklists¿) instructs users to regularly inspect their equipment, including their 14-volt batteries, and to avoid using equipment that appears damaged.Users are encouraged to replace any equipment that appears damaged.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.

• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14690021
• MDR Text Key: 296766458
• Report Number: 2916596-2022-11338
• 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: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: GV298-B039
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• 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: 28 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White