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

Catalog Number	050300000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Livanova received a report of a drop-by-drop blood leakage from revolution pump due to a crack of the unit.The event occurred during procedure.There was no patient injury.
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova manufactures the revolution centrifugal pump.The event occurred in mexico city, mexico.Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Thought follow up, livanova was informed the event occurred during the arterial and venous cannulation stage, before the initiation of the bypass.The procedure was interrupted for a few minutes needed for the replacement of the revolution pump.There was no blood loss.Patient was not affected and all the patient's hemodynamic parameters were in stable condition.A picture of the defect was provided: the outlet connector of the revolution pump was leaking.Since the change out of the device occurred prior to initiation of bypass, the support of the patient was not yet initiated and therefore the interrupion and the change-out of the pump has no impact on the patient.The short delay also has no impact on the patient.As for above, event is reassessed as not reportable.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.
Event or Problem Description
See initial report.

• Brand Name: REVOLUTION CENTRIFUGAL PUMP
• Common Device Name: 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; strada statale 12 nord, 86; mirandola 41037 ; IT 41037
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19947493
• Report Number: 9680841-2024-00023
• Device Sequence Number: 12602829
• Product Code: KFM
• UDI-Device Identifier: 38033178104778
• UDI-Public: (01)38033178104778(17)270304(10)2403040040(240)050300000
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 050300000
• Device Lot Number: 2403040040
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown