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 04/20/2022

Event Type  malfunction  

Event Description

It was reported that the patient was having a red light with associated error code b0013 while placing their batteries in the universal battery charger (ubc).This occurred with multiple batteries.No visible damage was noted.The patient received a new box of batteries.Replacing the batteries resolved the alarm.Related manufacturer's report # 2916596-2022-11056.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the 14v li-ion battery not being accepted for charge was unable to be confirmed; however, the 14v battery did display issues related to the error code reported.The 14v li-ion battery (serial number: (b)(4)) was returned for analysis and was functionally tested and passed.The battery was accepted for charge.The battery was able to operate a mock loop without alarms active.During further investigation, the rsoc voltage was intermittently dropping to 0v instead of the expected 4v on a full charge which may cause the reported b0013 error code to be displayed on the universal battery charger (ubc).The battery was opened in order to perform circuit analysis and the issue was able to be narrowed down to the component u11.The component was replaced and the suspected damaged component was placed on a test battery.The issue was unable to be reproduced on either battery following the replacement.No further testing was performed.The root cause of the reported event was unable to be conclusively determined through this investigation; however, it is suspected that there was an issue with the component u11.The device history records for the 14v li-ion battery (serial number: (b)(4)) were unable to be reviewed due the records being maintained by the vendor and are unavailable.Heartmate iii instructions for use (ifu) rev.C section 3 ¿ ¿powering the system¿ and the heartmate iii patient handbook rev.C section 3 ¿ ¿powering the system¿ addresses how to properly use the 14v battery clips and 14v li-ion batteries.Heartmate iii ifu rev.C section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook rev.C section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.The patient handbook cautions the 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: 14436846
• MDR Text Key: 292052165
• Report Number: 2916596-2022-11055
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• 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: GV174-B014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2021
• 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: 41 YR
• Patient Sex: Male
• Patient Weight: 108 KG