MAUDE Adverse Event Report: SORIN GROUP ITALIA SRL REVOLUTION CENTRIFUGAL PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Catalog Number UNKNOWN

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Event Description

On (b)(6) 2022, during literature review investigating 53 ecmo circuits from 46 pediatric patients, livanova was informed that 38 patients survived ecmo while 8 died.

Manufacturer Narrative

The item and lot of the involved revolution pumps are unknown.Based on article available information, it is not possible to discriminate neither if the revolution pump was assembled into a customized circuit nor was a stand-alone device.In usa, two revolution pump stand alone are cleared and distributed: (i) item 050300700 - revolution centrifugal blood pump with pc coating and (ii) 050300000 - revolution centrifugal blood pump.Since the item and lot of the involved revolution pumps are unknown, also the expiration date and udi are unknown.Livanova is not aware if the complained revolution pumps are available.The manufacturing dates are unknown.

• Brand Name: REVOLUTION CENTRIFUGAL PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• MDR Report Key: 15751622
• MDR Text Key: 303226111
• Report Number: 1718850-2022-01008
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2022
• Date Manufacturer Received: 10/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death