MAUDE Adverse Event Report: SORIN GROUP/LIVA NOVA REVOLUTION; CENTRIFUGAL PUMP

Lot Number 381419-2185

Device Problems Material Discolored (1170); Vibration (1674); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/06/2016

Event Type  Injury  

Event Description

Approx 45 minutes after ecmo was initiated, i rattle/vibration noise was heard from the ecmo circuit.Upon further investigation, it was noted that the upper bearing of the disposable centrifugal pump head appeared darkened or burnt.The circuit required replacement.

• Brand Name: REVOLUTION
• Type of Device: CENTRIFUGAL PUMP
• Manufacturer (Section D): SORIN GROUP/LIVA NOVA; arvada CO 80004
• MDR Report Key: 6030367
• MDR Text Key: 57680529
• Report Number: MW5065394
• Device Sequence Number: 1
• Product Code: DWA
• 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: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 381419-2185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 89