MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION BATTERY CLIP SET; VENTRICULAR (ASSIST) BYPASS

Model Number	2865
Medical Device Problem Codes	Corroded (1131); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while the patient was on vacation in jamaica, they experienced a connect power alarm even when two fully charged batteries were connected.Via a phone support, the patient exchanged their system controller and cleaned the contacts, but the issue could not be resolved.Further investigation showed that there was some corrosion on the contacts of the battery clip.No information was available about the root cause of the corrosion.Per the ventricular assist device (vad) coordinator advice, the patient organized some sandpaper and removed the corrosion which resolved the alarms.Once the patient returns from vacation, they were to present to the implanting center for a battery clip exchange.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of power cable disconnect alarms due to corrosion on the contacts of the 14v battery clips was unable to be confirmed.The 14v battery clip was not returned for analysis and no log files nor images were submitted for review.Additional information provided on 07mar2024 stated no information regarding the clips could be provided.A root cause for the reported event was unable to be conclusively determined through this analysis.The device history records for the heartmate 14v battery clip were unable to be reviewed due to no lot number being provided.Heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ and heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ under ¿guidelines for power cable connectors¿ explain how to properly connect and disconnect power cable connectors, including how to tighten the connector nut.Additionally, these sections address how to properly interpret and troubleshoot all system alarms, including power cable disconnect alarms.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.

• 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: 18941554
• Report Number: 2916596-2024-01464
• Device Sequence Number: 8381185
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Sex: Unknown