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

Catalog Number 03478

Device Problem Decreased Pump Speed (1500)

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

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The revolution centrifugal pump is a non-sterile device assembled into a sterile convenience pack (item 086267, lot 2103230018) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the oxygenator was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The complained revolution centrifugal pump is a non-sterile component assembled into a convenience pack that is not distributed in the usa.The standalone revolution centrifugal pump (catalog number 050300700) is registered in the usa (510(k) number: k190650).The device manufacture date refers to manufacture date of the sterile, finished convenience pack into which the oxygenator was assembled.Sorin group italia manufactures the revolution centrifugal pump.The incident occurred in cali valle del cauca, colombia.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The involved device is not available for investigation.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.Device not available.

Event Description

Livanova has received a report that, after 18 hours the ecmo procedure, when the revolution pump was at 3200rpm (4,8l/min) a loud sound was heard and flow dropped.The patient had been supported with pharmacology therapy and hand crack of emergency for 30 minutes until the pump was changed.There is no report of any patient injury.

Event Description

See intial report.

Manufacturer Narrative

Livanova has received a report of flow stop during an ecmo procedure, using a revolution pump.The unit was not made available for return.However, two videos of the involved revolution pump were provided and showed a damage to the revolution pump upper bearing.The analysis of the complaints database reveled that no further complaints related to the involved revolution lot have been reported.Dhr verification did not reveal any relevant information possibly linked with the claimed defect.The device passed all release tests, including spin test to verify correct rotation, without non conformities.Based on the collected information, livanova believes the flow stop was due to a damage of the revolution upper hub.To further investigate the root causes of the damage of the white upper hub of revolution pumps during usage in ecmo the capa-mir-2016-0007 was issued.The risk is in the acceptable region.No further action is deemed necessary.Livanova will maintain monitoring the market.

• Brand Name: REVOLUTION PHISIO 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, modena
• MDR Report Key: 12049592
• MDR Text Key: 257798208
• Report Number: 9680841-2021-00016
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2024
• Device Catalogue Number: 03478
• Device Lot Number: 2103010024
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention