MAUDE Adverse Event Report: SORIN GROUP ITALIA S.R.L. SORIN ECMO; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number SORIN ECMO 60S14180

Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Material Deformation (2976)

Patient Problem Loss of consciousness (2418)

Event Date 12/13/2021

Event Type  Injury  

Event Description

The np had his hand on the ecmo machine and inadvertently flipped the switch to off.The pump was immediately turned back on but the patient immediately began to lose consciousness.The pump was then moved to hand crank to restore flows.The patient had slouched down and his return cannula was kinked off which delayed the flows.Once the kink was fixed the flows were restored, the patient regained consciousness.The patient did not require cpr, and has no recollection of the event.The switch was taped to the on position with a tongue depressor.We have reached out to the sorin rep to see if there is any type of cover for the switch that can be applied to the machine.Fda safety report id# (b)(4).

• Brand Name: SORIN ECMO
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA S.R.L.
• MDR Report Key: 13257783
• MDR Text Key: 283958317
• Report Number: MW5106649
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SORIN ECMO 60S14180
• Was Device Available for Evaluation?: Yes
• 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; Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 99 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White