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

Catalog Number UNKNOWN

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 09/19/2022

Event Type  malfunction  

Manufacturer Narrative

Based on available information, livanova believes the involved device was a standalone revolution pump that was manually assembled to the competitor circuit by medical team.Livanova will try to obtain mor information.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

On 22 september 2022, during the inspection of a machine, sorin group italia has received a report that inspection done on unit because of an incident that occur during bypass on 19 september 2022 where the tubing on the disposable came off centrifugal revolution pump.During follow up with the customer it was clarified that the pump was a livanova centrifugal pump and a competitor pump pack.A leak occurred and it was not minimal.The medical team clamped the inflow of the tubing connected to centrifugal pump and reconnect the outflow.They were able to go back on bypass and come off safe.There is no report of any patient or user injury.

Manufacturer Narrative

According to verification, with livanova customer service, this customer ordered stand alone revolution item catalogue 050300700 and/or 050300000.It remains unknwonw which item was involved.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

Since the complained revolution pump was used with a competitor circuit, it is highly reasonable to assume that the connection between the centrifugal pump and the disposable tube was not assembled by livanova.No concerning trend has been identified for similar issues.A livanova service engineer verified the s5 console in use and no issue could be identified: the console was tested, declared fully functional and put back into service.The most probable root cause was an unproper connection made by the user between the centrifugal pump and the disposable tubing.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• 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
• Manufacturer (Section G): SORIN GROUP ITALIA SRL; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w 65th way; arvada, CO 80004
• MDR Report Key: 15649518
• MDR Text Key: 304825369
• Report Number: 9680841-2022-00046
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: No
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1