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

Model Number 2465

Device Problem Mechanical Problem (1384)

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

Event Date 01/17/2024

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of ¿chipping battery contacts¿ was confirmed with the returned 14v battery serial # (b)(6).Visual inspection of the returned 14v battery revealed the metal contacts were corroded.Of note, the corroded area does not contact the electrical contacts within the battery clip/charging slot and did not result in a specific functional issue during testing.The battery was inserted into a test universal battery charger and was accepted for charge with no error code.The battery was charge/discharge tested with an electronic load based battery test system, which met discharge time requirement.A root cause that led to the corroded battery contacts could not be determined through this analysis.14v battery serial # (b)(6) was manufactured on 06oct2022 by the supplier.The battery was received for inspection under batch number 8721601.Heartmate 3 patient handbook rev g, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5 ¿alarms and troubleshooting¿ describes all alarms (visual and audible) and what action should be performed when they do occur.Under section 3, powering the system, describes how to use both 14v battery and 14v battery clips.Under section 8, ¿equipment storage and care" describe how to care for and clean all equipment.Heartmate 3 instructions for use rev g, under section d, safety checklists, replace any equipment or system component that appears damaged or worn.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that three batteries were replaced for damaged pins/chipping contacts.Related regulatory reference report mfr # 2916596-2024-01713.Related regulatory reference report mfr # 2916596-2024-01716.

• 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: 18970739
• MDR Text Key: 338699179
• Report Number: 2916596-2024-01715
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: 00813024010692
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 8783494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2022
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 86 KG