MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL ECMO #2, LIVANOVA SCP/REVOLUTION; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

Perfusionist saw extracorporeal membrane oxygenation (ecmo) machine control display began to flash on and off showing random numbers.Ceased to generate rotations per minute (rpm)s to the pump drive.While donning personal protective equipment (ppe), perfusionist asked nurse in the bed space to try and push in all electrical connections.Perfusionist informed a nurse outside the bed space of issue and to alert the attending physician and respiratory therapist.Perfusionist entered the bed space, powered down ecmo machine and powered up ecmo machine, which did not resolve the equipment malfunction.Perfusionist began hand-cranking the pump.Perfusionist asked bed space nurse to hand crank while the perfusionist continued to troubleshoot, powering down the unit and removing and plugging in all electrical connections.This was not successful.Outside of bed space nurse was asked by perfusionist to call the operating room to request back up perfusionist bring a cardiopulmonary bypass (cpb) machine to bed space to replace ecmo machine.Perfusionist, nurse, and respiratory therapist rotated through hand cranking ecmo until the cpb machine was brought to bed space.Perfusionist switched from hand crank to cpb machine.

• Brand Name: ECMO #2, LIVANOVA SCP/REVOLUTION
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; 14401, west 65th way; arvada CO 80004
• MDR Report Key: 10407002
• MDR Text Key: 202910706
• Report Number: 10407002
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/05/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/14/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA