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 11/07/2023

Event Type  malfunction  

Event Description

It was reported that the patient brought in two bad batteries that were then replaced.The patient stated that the batteries did not hold a charge and turned red in the charger.Related mfr.Report # 2916596-2024-01875.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of the heartmate 14 volt lithium ion battery (serial number (b)(6) not being able to hold a charge and having a red light battery fault on the universal battery charger (ubc) was confirmed via analysis of the returned product.During the evaluation, the reported event was confirmed when the battery was placed on a test ubc and a red light fault associated with a voltage cross check issue was active (b0010).The 14v li-ion battery alarmed for low voltage when connected to the controller but was able to operate system despite the alarms.The 14v li-ion battery was opened and no physical anomalies were observed.Circuit analysis was performed on the printed circuit board (pcb) revealing that the circuit responsible for the relative state of charge voltage was not outputting the appropriate voltage for a fully charged battery.A root cause for the reported event could not be isolated to a single component within the circuit.Battery inspection data was reviewed for the 14v battery, serial number sw250121, revealing that the battery passed all inspection testing.The 14v battery was shipped to the customer on 25sep2022 and was assigned to the patient on 18oct2022.Heartmate 3 instructions for use (rev.C) section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.D) section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (visual and auditory), including battery faults displayed on the universal battery charger (ubc), and the actions to take if the issue does not resolve.Heartmate 14 volt li-ion battery instructions for use (ifu) (rev.E) explains the operation of batteries in the heartmate system.The ifu explains how to use the 14v batteries, including how to connect the 14v batteries to the appropriate battery clips, how to charge the battery, and how to check the charge level of the battery.Heartmate 3 patient handbook (rev.D) section 3 ¿ ¿powering the system¿ and heartmate 3 instructions for use rev.C) section 3 ¿ ¿powering the system¿ explains the operation of 14v batteries in the heartmate system, including that the 14v batteries are usable for approximately 360 use/charge cycles or for 36 months from the date of manufacture, whichever comes first.This section also informs the user to not use expired batteries.Additionally, section f of the ifu entitled ¿safety checklists¿, informs the user to check the manufacture date on the label of all batteries.If a battery was manufactured more than three years ago, the battery has expired.Replace expired batteries.Do not use expired batteries.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 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: 18979029
• MDR Text Key: 339003272
• Report Number: 2916596-2024-01874
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: 00813024010692
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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: SW250-B029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 70 KG