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

Model Number 1340

Device Problems Use of Device Problem (1670); Electrical Power Problem (2925)

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

Event Date 05/24/2022

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 the patient's power module had "loud howling alarm sounds" 5 days after they were implanted with a heartmate 3 lvas.The yellow wrench and red battery alarms illuminated on the device.The power module backup battery did not work, so their power source was switched to batteries.The patient did not experience any adverse events as a result of the event and their flow remained stable.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of loud howling alarms, red battery and yellow wrench alarms, and the power module battery not working was not confirmed.Additional provided information communicated on 02jun2022 stated that no more information can be obtained in clarifying the alarms.The system controller, power module, and system monitor were involved with the event.No log files were obtained.The event resolved by changing the patient to batteries.Additional provided information communicated on 27jun2022 stated that the serial number was not able to be located.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were unable to be reviewed due to the serial number of the power module being unknown.Heartmate iii instructions for use (ifu) section 3 entitled ¿powering the system¿ and heartmate iii patient handbook section 3 entitled ¿powering the system¿ addresses how to properly switch between power sources.This section also provides ample information on the power module backup battery: how to install it, uninstall the battery.How to charge the battery, support time, etc.Heartmate iii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly address and interpret all system alarms including red battery and yellow wrench advisory alarms.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 maintain and store the equipment for proper use.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
• 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: 14575295
• MDR Text Key: 293193313
• Report Number: 2916596-2022-11409
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: 00813024010654
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

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 Catalogue Number: 1340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/31/2022
• Initial Date FDA Received: 06/02/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 188 KG