MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH RENTAL, CENTRIMAG MOTOR; Pump, blood, cardiopulmonary bypass, non-roller type

Model Number L102956

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 03/19/2024

Event Type  Death  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that following an elective transcatheter aortic valve replacement procedure, the patient had ventricular fibrillation and ventricular tachycardia and was placed on extracorporeal membrane oxygenation.After the patient was initiated on the motor, there was an m4 motor alarm.The motor operated as intended, except when the motor cable was manipulated.When the motor cable was manipulated, the blood pump sounded ¿off balance¿ and made a noise, and then the patient flows would decrease a little.As long as the motor cable was not manipulated, the motor worked.The motor was changed out very soon after this issue was noticed; the patient did not spend a lot of time using the affected motor.The patient passed away a few hours after the motor issue was noted.The death was not considered to be related to centrimag motor failure.

• Brand Name: RENTAL, CENTRIMAG MOTOR
• Type of Device: Pump, blood, cardiopulmonary bypass, non-roller type
• 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: 19083345
• MDR Text Key: 339854958
• Report Number: 3003306248-2024-00465
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: (01)07640135140078(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 93 KG