MAUDE Adverse Event Report: THORATEC CORP. CENTRIMAG 2ND GEN; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Lot Number 201-30300

Device Problems No Display/Image (1183); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2023

Event Type  Injury  

Event Description

M1 no flow alarm on ecmo machine, console screen flickering, monitoring screen black, no flow observed.

• Brand Name: CENTRIMAG 2ND GEN
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORP.
• MDR Report Key: 16411735
• MDR Text Key: 310006912
• Report Number: MW5115078
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2023
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male