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

Catalog Number 03598

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Hypoxia (1918)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Patient information were not provided.The complained revolution pump 5 is a non-sterile device assembled into a sterile convenience pack (item ecm0011; lot 2012150039) that is not distributed in the usa.The expiration date refers to the sterile finished product into which the revolution pump was assembled.As the sterile convenience pack is not distributed in usa, the udi number is not applicable.The complained revolution pump 5 item 03598 is similar to the revolution phisio centrifugal pump item 050300700, which is distributed in the usa, for which the device identifier is 08033178104791.The complained revolution pump 5 item 03598 is similar to the revolution phisio centrifugal pump item 050300700, which is distributed in the usa (510(k) number: k190650).The device manufacture date refers to manufacture date of the non sterile, finished revolution.Sorin group(b)(4) manufactures the revolution pump 5.The incident occurred in (b)(4).The involved device has been requested and received at sorin group (b)(4) for investigation.Through follow-up communication livanova learned that no inlet pressure monitoring system was used during procedure.Reportedly decrease in flow was noticed and the user tried to solve the problem by increasing pump rpms.Noradrenaline (vasoconstrictor effect drug) was administered to the patient.In addition, livanova learned that the patient is no longer on ecmo support and currently in respiratory weaning.If any additional information pertinent to the reported event is obtained, it will be provided in a supplemental report.

Event Description

Sorin group (b)(4) received report from ansm (ref.(b)(4) that ecmo support was started on (b)(6) 2021 on a covid-19 patient with severe hypoxemia and giant subcutaneous emphysema on tracheal wound.During the night of (b)(6) 2021 the revolution pump stopped and the patient saturation was spo2=60%.The user hand-cranked the pump to continue the support and spo2 = 80% was registered.Reportedly, while hand-cranking, it was difficult to achieve the target flow rate (flow could not go beyond 2 l/min) and noise could be heard from the pump head.The user replaced the centrifugal pump and the circuit.A misalignment of the pump head was observed.In addition, it was reported that no clots could be observed at the level of the pump head.

Manufacturer Narrative

The received revolution pump belonged to a lot number that is not the lot provided at the submission of the case.Livanova followed up with the customer to clarify if the complained revolution device is still available and was informed that no other revolution pump is available.The analysis of the complaints database reveled that no further similar complaints related to the same lot of the complained revolution pump has been reported.Dhr verification of the lot of the complained revolution pump did not reveal any relevant information possibly linked with the claimed issue.The device passed all release tests, including spin test to verify correct rotation, without non conformities.Based on the available information, livanova believes that the most probable root cause of the reduced flow was a damage of the revolution upper hub.Corrective action and preventive action was issued to address the issue related to the damage of the white upper hub of revolution pumps during usage in ecmo.No further specific action was currently deemed necessary, livanova maintains monitoring the market.

Event Description

See intial report.

• 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
• 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: 11853990
• MDR Text Key: 265612853
• Report Number: 9680841-2021-00013
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2023
• Device Catalogue Number: 03598
• Device Lot Number: 2009230033
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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): Other