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 Hemolysis (1886)

Event Type  Injury  

Event Description

On (b)(6) 2022, during literature review investigating 53 ecmo circuits from 46 pediatric patients, livanova was informed that 6 patients (11%) showed thrombus that embolized to the pump.The pump thromboemboli were not adherent, instead, they were typically long thin clots that wrapped around the rotor blades and struts.Three of six patients with pump thromboemboli showed increased hemolysis.

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 item and lot are unknown.Therefore, the manufacturing dates are unknown.Sorin group italia manufactures the revolution pump.The incidents occurred in seattle, wa, united states.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

See intial report.

Manufacturer Narrative

On 11 october 2022, during literature review, livanova was informed that 6 patients showed thrombus that embolized to the pump.The pump thrombo-emboli were not adherent, instead, they were typically long thin clots that wrapped around the rotor blades and struts.Three of six patients with pump thrombo-emboli showed increased hemolysis.Additionally, livanova was informed that 38 patients survived ecmo while 8 died.Livanova is not aware if any of the complained revolution pumps are available.The catalogue items and lots are unknown.Therefore, the manufacturing dates are unknown.Livanova has attempted to contact the author of the paper.However, no response was received.It shall be noticed that hemolysis is a known risk while using a centrifugal pumps.A device contribution in the reported hemolysis cannot be ruled out.However, also patient condition and clinical practices can be the reason of the hemolysis.In addition, in the paper there is not a clear statement on the correlation between the reported deaths and any livanova product.Additionally, it was not clarified in any livanova device was is use during the procedure resulted in patient death.If any additional information pertinent to the reported event and impacting the investigation results is received, this event will be re-evaluated.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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: 15751626
• MDR Text Key: 303243464
• Report Number: 9680841-2022-00049
• 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: Literature
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/08/2022
• Supplement Dates Manufacturer Received: 11/21/2022
• Supplement Dates FDA Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other