CENTRIFUGAL PUMP REVOLUTION 5
Report
- Report Number
- 9680841-2023-00034
- Event Type
- Malfunction
- Date Received
- August 3, 2023
- Date of Event
- May 12, 2023
- Report Date
- October 19, 2023
- Manufacturer
- SORIN GROUP ITALIA
- Product Code
- KFM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
A.1.-A.5. PATIENT INFORMATION WAS NOT PROVIDED. D.4. THE CENTRIFUGAL PUMP REVOLUTION 5 IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE PUMP WAS ASSEMBLED. AS THE STERILE CONVENIENCE PACK IS NOT DISTRIBUTED IN USA, THE UDI NUMBER IS NOT APPLICABLE. G.5. THE COMPLAINED CENTRIFUGAL PUMP REVOLUTION 5 IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS NOT DISTRIBUTED IN THE USA. THE STAND ALONE PUMP (CATALOG NUMBER 050300700) IS REGISTERED IN THE USA (510(K) NUMBER: K190650). H.4. THE DEVICE MANUFACTURE DATE REFERS TO MANUFACTURE DATE OF THE STERILE, FINISHED CONVENIENCE PACK INTO WHICH THE PUMP WAS ASSEMBLED. H.10. LIVANOVA MANUFACTURES THE CENTRIFUGAL PUMP REVOLUTION 5. THE INCIDENT OCCURRED IN FRANCE. THE INVOLVED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP ITALIA FOR INVESTIGATION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
THE COMPLAINED PUMP WAS RECEIVED AT LIVANOVA FOR INVESTIGATION. VISUAL INSPECTION FOUND THE UPPER HUB IS PARTIALLY WORN AND THE IMPELLER IS DAMAGED. THUS, THE IMPELLER LIFTED UP AND APPLIED PRESSURE ON THE UPPER BEARING, LEADING TO ITS DAMAGE. THE ANALYSIS OF THE LIVANOVA COMPLAINTS DATABASE DID NOT IDENTIFY ANY OTHER SIMILAR COMPLAINT RELATED TO THE INVOLVED REVOLUTION LOT OUT OF (B)(4) MANUFACTURED UNITS. ACCORDINGLY, 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, THE REPORTED NOISE DURING THE PROCEDURE WAS DUE TO DAMAGE OF THE REVOLUTION UPPER HUB RELATED TO THE PRESENCE OF POSSIBLE BLOOD CLOTS AND/OR DEVICE MECHANICAL ISSUE. A CAPA WAS LAUNCHED TO INVESTIGATE DAMAGE OF THE WHITE UPPER HUB OF REVOLUTION PUMPS DURING ECMO PROCEDURES. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY. LIVANOVA WILL KEEP MONITORING THE MARKET.
LIVANOVA WAS INFORMED THAT THE PATIENT HAS BEEN RELEASED FROM INTENSIVE CARE ON (B)(6) 2023. THE PATIENT HAS BEEN SEEN IN CONSULTATION ON (B)(6) 2023 WITH RECOVERY ALLOWING AUTONOMY IN THE ACTS OF DAILY LIFE. THE EVENT HAS BEEN REASSESSED AS MALFUNCTION. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, AROUND 3H30 IN INTENSIVE CARE UNIT, THE PERFUSIONIST WAS ALERTED DUE TO ECMO FLOW WAS AT 0 RPM WITH NOISE COMING FROM THE REVOLUTION CENTRIFUGAL PUMP. NO FLOW WAS OBTAINED EVEN WHEN USING THE EMERGENCY HAND CRANK. PATIENT ARTERIAL SATURATION AT 38%. THE MEDICAL TEAM ELECTED TO REPLACE THE CIRCUIT. PATIENT CONDITIONS HAVE NOT CLARIFIED, INVOLVED DEVICE IS AVAILABLE FOR INVESTIGATION.
SEE INTIAL REPORT.
SEE INTIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1658120 | CENTRIFUGAL PUMP REVOLUTION 5 | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | SORIN GROUP ITALIA | 03598 | 2208300015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |