MAUDE Adverse Event Report: LIVANOVA / SORIN GROUP ITALIA S.R.L. REVOLUTION CENTRIFUGAL BLOOD PUMP COATED; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 050300700

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Event Description

Revolution head leaking during priming of heart lung machine.No patient interaction.Fda safety report id# (b)(4).

• Brand Name: REVOLUTION CENTRIFUGAL BLOOD PUMP COATED
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): LIVANOVA / SORIN GROUP ITALIA S.R.L.
• MDR Report Key: 13315232
• MDR Text Key: 284351272
• Report Number: MW5106857
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 050300700
• Device Lot Number: 550894-0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1