MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH / ABBOTT LABORATORIES CENTRIMAG PRIMARY CONSOLE ECMO; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problem Defective Device (2588)

Patient Problem No Code Available (3191)

Event Date 08/08/2019

Event Type  malfunction  

Event Description

The pt was transferred to (b)(6) (b)(6) 2019 post episode of hypotension arrest / bradycardia / respiratory failure and placed on ecmo therapy.The console gave an s3 system alert on (b)(6) 2019 at 01:15.The rpm's went from 4500 to 3500 and flow through the sensor was not reading on the console screen.Staff member consulted the troubleshooting guide; tried acknowledging the alarm, but there was no resolution.The guide directed to move to the backup console, centrifugal motor and flow probe which was done and provided immediate resolution of the problem.Another ecmo console was brought up and the malfunctioning items were replaced ie console, pump and probe.The pt was removed from ecmo therapy on (b)(6) 2019.She left the facility on (b)(6) 2019 against medical advice; she had been advised of not being ready for discharge but was deemed competent to make decisions.The product has a centrimag 2nd generation primary console; serial # (b)(4).Centrimag motor; serial# (b)(4).

• Brand Name: CENTRIMAG PRIMARY CONSOLE ECMO
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH / ABBOTT LABORATORIES
• MDR Report Key: 9076120
• MDR Text Key: 159120796
• Report Number: MW5089836
• 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: Nurse
• Type of Report: Initial
• Report Date: 09/05/2019
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2019
• 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 Age: 34 YR
• Patient Weight: 100