MAUDE Adverse Event Report: MAQUET GETINGE GROUP ROTOFLOW CONSOLE; ECMO

Model Number 70105.1712

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 10/21/2020

Event Type  Death  

Event Description

Patient in ccu underwent elective ecmo cannulation >cardiac arrest > sternotomy at bedside.Providers concerned that ecmo may have been faulty.Autopsy in progress.

• Brand Name: ROTOFLOW CONSOLE
• Type of Device: ECMO
• Manufacturer (Section D): MAQUET GETINGE GROUP ; 45 barbour pond dr.
• MDR Report Key: 11309463
• MDR Text Key: 231389358
• Report Number: 11309463
• Device Sequence Number: 1
• Product Code: KFM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2020,08/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70105.1712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2020
• Distributor Facility Aware Date: 10/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 44 YR