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

Model Number 2465

Device Problem Corroded (1131)

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

Event Date 04/19/2022

Event Type  malfunction  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that patient had visible corrosion on their battery contacts.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of corrosion on the 14v li-ion batteries was able to be confirmed via an image provided by the customer.The 14v li-ion battery (serial number:(b)(6) was not returned for analysis and no log files were submitted for review.Additional information provided on 21apr2022 stated that the 14v li-ion batteries will be returning once the new batteries arrived.Multiple good faith efforts were made to confirm if the batteries will be returning, however, no response was received.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records for the 14v li-ion battery (serial number: (b)(6) were unable to be reviewed due to the records being maintained by the vendor and are unavailable.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use including how to ensure that the controllers and equipment do not get wet.Heartmate iii patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the 14v battery clips and 14v batteries.Section 10, entitled ¿safety checklists¿, provides checklists to assist the patient in performing routine maintenance of heartmate iii lvad, including the 14v battery clips and 14v batteries.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: 14186568
• MDR Text Key: 289870388
• Report Number: 2916596-2022-10548
• 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: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/18/2022
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: ST352-B004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2019
• 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: 107 KG