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

Catalog Number 050300700

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/04/2022

Event Type  Injury  

Event Description

Livanova received report that during a procedure a blood leak was noticed at the level of the revolution pump.Reportedly, the leak seems to be located at the level of the pump head and not at the connections.Reportedly, the customer took extra care to monitor the leak in case it would get worse.However, the pump was continued to be used and procedure was completed successfully with no patient consequences and no delay in the surgery.Moreover, it was also stated that during priming, there probably was a small leak but customer thought it was condensation from the oxygenator thus decision was taken to go on bypass and then the blood leak was noticed.In addition, it was reported that the patient was a male 64 years old man (length 187 weight 120 kg body surface area 2.44m2.) with infectious endocarditis on the aortic valve.The surgical procedure was for embolectomie right leg and aortic valve replacement.The following pre-existing conditions were stated: arterial hypertension, ex-smoker, hypertrophic prostate, history of alcohol abuse, alcoholic liver cirrhosis, stenosis on the mesenteric artery, sepsis, obesity, vascular disease, psychiatric history, dyslipidemia.It was communicated by the customer that the patient died the day after the surgery and that the death was not related to reported leak at the revolution pump.

Manufacturer Narrative

Patient information were not provided.Sorin group italia manufactures the revolution centrifugal blood pump with pc coating.The incident occurred in united kingdom.The involved device has been received ans sent to gamma ray decontamination.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Livanova received a report of a fluid leak during a procedure phase.As per customer's notes, the patient died the day after due to pre-existing severe conditions.No pictures or video showing the defect was made available.The unit was received at livanova for investigation.Visual inspection did not highlight any sign of damage/fracture across the top welding area of the revolution pump.A leak test of the pump confirmed a leak from the welding region between top and body was reproduced: the complained issue was confirmed.Dhr review of the complained lot did not highlight any deviation or non-conformity possibly related to occurred issue.No further similar complaints have been recorded for complained lot.Based on above findings, the most likely root cause of reported failure has been reasonably assigned to a minor crack of the pump cover related to accidental impact / rough handling of the device.Considering that pumps are 100% verified during manufacturing process and that no similar event has been reported it cannot be excluded that device was damaged during shipping/transportation phase.As initially stated, patient outcome was not related to any device issue.The risk is in the acceptable region.No other specific action was currently deemed necessary, livanova will keep monitoring the market.

• Brand Name: REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
• 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: 15390339
• MDR Text Key: 299558948
• Report Number: 9680841-2022-00037
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 08033178104791
• UDI-Public: 01080331781047911724091310210915001811
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 050300700
• Device Lot Number: 2109150018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/15/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 120 KG