MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC HEARTMATE 3 SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS

Catalog Number 106531US

Device Problems Loose or Intermittent Connection (1371); Unexpected Therapeutic Results (1631)

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

Event Date 03/01/2022

Event Type  malfunction  

Event Description

While speaking with the patient on the phone, i heard an intermittent vad alarm.One that is a/w power cable disconnect usually.I asked the patient what was that and she confirmed my suspicion.She said it has been doing that for months.Asked why she didn't report it she said she didn't think it was a problem.She said it occurred with certain motions, the alarms was brief and didn't cause any untoward symptoms, so she thought it must me ok.She came in today and i replaced the system controller.And will return the controller to the manufacturer for investigation.

• Brand Name: THORATEC HEARTMATE 3 SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6101 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 14192351
• MDR Text Key: 289972066
• Report Number: 14192351
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 106531US
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1