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

Device Problem Protective Measures Problem (3015)

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

Event Date 04/11/2022

Event Type  malfunction  

Event Description

The patient's son called this morning to report the patient suddenly had a controller fault alarms following the self test.The patient felt well, however was anxious about the alarm.The display screen on the controller indicated to change controller.He did as directed, to call before changing the controller, if it was a caution alarm.The patient came in and controller was replaced without incident.New controller # (b)(4).Waveforms were sent to the manufacturer.Controller will be sent back to the manufacturer for evaluation.Patient safety report filed.

• 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: 14192347
• MDR Text Key: 289971839
• Report Number: 14192347
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/11/2022
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/25/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1