MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; Control, pump speed, cardiopulmonary bypass

Model Number 201-30300

Device Problem Insufficient Information (3190)

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

Event Date 04/05/2024

Event Type  malfunction  

Manufacturer Narrative

A1-a4: patient information not provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the centrimag console stopped working during patient support with an s3 alarm.The patient was immediately converted to a backup system to take over support of the patient.It was noted that no log files were available from the event.There were no patient symptoms.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: Control, pump speed, cardiopulmonary 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: 19184700
• MDR Text Key: 341121783
• Report Number: 2916596-2024-02189
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140894
• UDI-Public: (01)07640135140894(10)L06786
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2024

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: Health Professional
• Device Model Number: 201-30300
• Device Lot Number: L06786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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