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

Model Number 201-10002

Device Problems Insufficient Information (3190); Noise, Audible (3273)

Patient Problem Cardiac Arrest (1762)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

A4 - patient weight 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 there were suddenly acoustic alarm sounds from the console.The motor made a strange rattling noise, and the screen showed no flow.The patient went into arrest and advanced resuscitation maneuvers were initiated, as well as high inotropic support.They performed an emergency change; they went to the backup motor and backup console.Flow was reestablished and the patient came out of arrest.It was noted that the patient had been on extracorporeal membrane oxygenation (ecmo) support since 27dec2023 for tracheoesophageal fistula/acute respiratory distress syndrome (ards).Sometime after the emergency, when the console was turned on an s3 alarm appeared.The patient was hemodynamically stable.Related manufacturer reference number: (b)(4) (centrimag console).Related manufacturer reference number: (b)(4) (centrimag blood pump).Related manufacturer reference number: (b)(4) (centrimag flow probe).

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18725540
• MDR Text Key: 335709472
• Report Number: 3003306248-2024-00407
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/30/2024
• 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): Required Intervention; Life Threatening
• Patient Age: 3 MO
• Patient Sex: Female