MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524INT

Device Problem Noise, Audible (3273)

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

Event Date 07/10/2022

Event Type  malfunction  

Event Description

It was reported that the pump was making intermittent unusual sounds.Log file analysis showed that the right ventricular assist device (rvad) and left ventricular assist device temperature (lvad), rotor displacement and rotor noise appeared to be normal.The patient was stable and no alarms were noted.The cause of the unusual sounds were not determined.The site conducted routine testing but could not determine a cause.It was not known whether the issues resolved.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported of an intermittent, abnormal sound coming from the heartmate 3 ventricular assist device, serial number (b)(4), could not be confirmed through this evaluation.A specific cause for the reported event could not be conclusively determined and a direct correlation with (b)(4) could not be conclusively established through this evaluation.The submitted log files were reviewed and found that the pump operated at the set speed without issue.The system appeared to be operating as intended, and there were no notable alarms active in the log files.The patient remains ongoing on (b)(4) with no further reported issues at this time.The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications the heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ and section 6 ¿patient care and management¿ of the ifu, instruct the user to notify appropriate personnel if there is a change in how the pump works, sounds, or feels.The heartmate 3 lvas patient handbook, is currently available.The sections entitled ¿introduction¿ and ¿living with the heartmate 3¿ state to call your hospital contact right away if you notice a change in how your pump sounds, feels, or works.Even small changes should be reported.The section entitled ¿handling emergencies¿ explains to ¿call your doctor right away if you notice a sudden change in how your pump is working (even if there is no alarm).Remember, you know best what is normal for you and your pump.The patient handbook instructs the user to call their hospital contact if the user thinks, for any reason, any portion of the equipment is not functioning as usual, is broken, or the user is uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 15133607
• MDR Text Key: 302593338
• Report Number: 2916596-2022-12260
• Device Sequence Number: 1
• Product Code: DSQ
• 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: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/23/2022
• Device Model Number: 106524INT
• Device Lot Number: 7542590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 94 KG