MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION BATTERY CLIP SET; Ventricular (assist) bypass

Model Number	2865
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the 14-volt battery clip was returned for evaluation due to the reported event of low voltage alarms.A review of the submitted log files revealed intermittent low voltage and power cable disconnect alarms while the patient was connected to batteries.The 14v battery clip (lot number: 10013642) was returned for analysis.Corrosion was noted on some the terminal contacts.The 14v battery clip was tested together with laboratory test equipment.Test battery was installed into the battery clip.The test battery in the battery clip was secured within the housing.The battery clip release mechanism was checked and was unremarkable.The test system controller¿s power connectors were able to fully mate with the battery clip without any issue.Connected a test pump and the system operated.Manipulation of the test 14v battery with the returned 14v battery clip showed no issues.Connecting a second 14v battery/clip reproduced a power cable disconnect alarm likely caused by the observed corrosion.A specific cause for the corrosion on the terminal contacts cannot be conclusively determined through this evaluation.The device history records were reviewed for the 14v battery clip (lot number: 10013642) and was found to pass all manufacturing and qa specifications before being shipped to the customer.Heartmate 3 instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including low voltage and power cable disconnect alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 instructions for use section 3 ¿ ¿powering the system¿ and heartmate 3 patient handbook section 3 ¿ ¿powering the system¿ addresses how to properly use the 14v battery clip.Heartmate 3 patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the 14v battery clip.This includes cleaning the metal battery contacts and the interior contacts of battery clips monthly to ensure the best possible performance.Additionally, section 10 entitled ¿safety checklists¿ instructs users to regularly inspect their accessories ¿ including their battery clips ¿ for damage, and to replace any equipment that appears damaged or worn.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.
Event or Problem Description
It was reported that the patient had a low voltage advisory alarm that was not resolved even after the battery and battery clip were replaced.The patient went to the hospital outpatient and the battery and battery clip had rusted and corroded terminals.The cause of the corrosion on the terminals was unknown.The alarms stopped when the mobile power unit (mpu) was used.The system controller, two batteries, and four battery clips were replaced with new ones.The event log files captured several odd low power advisories when the patient was connected to the batteries.There were no other unusual events captured.There was no patient impact.

• Brand Name: HEARTMATE®, 14V LI-ION BATTERY CLIP SET
• 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: 20685689
• Report Number: 2916596-2024-07232
• Device Sequence Number: 8584617
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715(10)10013642(11)231020
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: 2865
• Device Catalogue Number: 2865
• Device Lot Number: 10013642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 58 KG