MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE POWER MODULE BACKUP BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number 1340

Device Problems Alarm Not Visible (1022); Use of Device Problem (1670)

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

Event Date 01/25/2024

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the power module lights and alarms would not display when the battery was connected.The heartmate power module backup battery was exchanged and the power module was working properly after a self-test was performed.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the reported event of the power module lights/alarms not illuminating when the backup battery was connected was confirmed via evaluation.The heartmate power module backup battery (s/n: (b)(6) was returned for analysis.The power module backup battery had a measured voltage of 6.80v.The 12v battery was connected to a test power module fixture and the power module symbols did not illuminate.The 12v battery underwent a charging cycle, however the battery was unable to fully charge.The 12v battery was reconnected to the power module fixture and a mock loop and the yellow charge symbol was illuminated followed shortly by the red battery and yellow wrench symbols.The alternating current (ac) power cord was unplugged, and the backup battery was unable to supply power to the system.Further evaluation was not performed due to the chemical hazard posed by sealed lead acid batteries.Of note, the backup battery was observed to have been manufactured on 20dec2022 and was therefore not expired at the time of the reported event.Per the provided information, exchanging the battery resolved the event.The root cause for the reported event was unable to be conclusively determined through this analysis.Battery inspection data was reviewed for the 12v sla backup battery, serial number (b)(6), revealing that the battery passed all testing per the greatbatch specifications.The battery was shipped to the customer on 11aug2023.Heartmate 3 instructions for use section 7 - ¿alarms and troubleshooting¿ and heartmate 3 patient handbook 5 - ¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot atypical alarms, including all power module alarm conditions.Heartmate 3 instructions for use section 8 - ¿equipment storage and care¿ and heartmate 3 patient handbook section 6 - ¿caring for the equipment¿ explain how to properly care for all the equipment to prevent damage.Once every three years the power module internal battery will be replaced with a new internal battery.Heartmate 3 instructions for use section 3 - ¿powering the system¿ states that the power module contains an internal backup battery that provides approximately 30 minutes of backup power to the system during a power emergency.It instructs to keep the power module plugged into ac power at all times to make sure that the power module backup battery is charged and ready for use in case of power interruption.If the power module is without ac power for approximately 18 hours or more, the power module backup battery may be damaged.Additionally, it is stated that if the power module backup battery is not installed or connected when the power module is plugged in, the power module alarms, indicating that it cannot provide backup power in the event of a power interruption.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 POWER MODULE BACKUP BATTERY
• 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: 18691259
• MDR Text Key: 336396227
• Report Number: 2916596-2024-00671
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: 813024010654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 1340
• Device Lot Number: GW354
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 05/09/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 101 KG