MAUDE Adverse Event Report: THORATEC CORP. CENTRIMAG MOTOR; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 2020-09-17

Device Problems Mechanical Problem (1384); Defective Component (2292); No Flow (2991)

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

Event Date 02/15/2023

Event Type  malfunction  

Event Description

Went to transfer ecmo circuit from bed to stretcher and pump head motor started grinding and lost all flows.Backup console and pump head were setup.Ended up clamping out pump head was taken out of defective pump head and placed in backup motor and came back on full flow.Reference report #mw5115399.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORP.
• MDR Report Key: 16477788
• MDR Text Key: 310787937
• Report Number: MW5115398
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/28/2023

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: 2020-09-17
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Female