MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG MOTOR, OUS; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-10002

Device Problems Decreased Pump Speed (1500); Infusion or Flow Problem (2964); Noise, Audible (3273)

Patient Problem Cardiac Arrest (1762)

Event Date 02/06/2024

Event Type  Injury  

Event Description

It was reported that the patient was diagnosed with pneumonia and acute respiratory distress syndrome (ards).They were transferred to computed topography (ct) and when they moved, the motor suddenly generated a rattling noise.The flow and rpm dropped to zero and the patient went into cardiac arrest; it was noted that the customer reported that there were no alarms.Advanced resuscitation maneuvers were performed as well as high inotropic support.The centrifuge and circuit were checked, and no air or thrombus were evident.An emergency change to the motor and console was performed and flow restored; the patient came out of cardiac arrest.Related manufacturer reference number: 2916596-2024-00968 (centrimag console).

Manufacturer Narrative

A2, a4: patient age and weight not provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: CENTRIMAG MOTOR, OUS
• 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: 18760816
• MDR Text Key: 336055293
• Report Number: 2916596-2024-00967
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K020271
• 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
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Device Lot Number: 7234850
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Life Threatening
• Patient Sex: Female