REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING
Report
- Report Number
- 9680841-2022-00038
- Event Type
- Malfunction
- Date Received
- September 14, 2022
- Date of Event
- August 18, 2022
- Report Date
- November 11, 2022
- Manufacturer
- SORIN GROUP ITALIA SRL
- Product Code
- KFM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PATIENT INFORMATION HAS NOT BEEN PROVIDED. THE REVOLUTION PUMP PC IS A NON-STERILE DEVICE ASSEMBLED INTO A STERILE CONVENIENCE PACK (CATALOGUE 044053500 - SC WICHITA METRO WICHTA KS 1, LOT 2219400022) THAT IS DISTRIBUTED IN THE USA. THE EXPIRATION DATE REFERS TO THE STERILE FINISHED PRODUCT INTO WHICH THE OXYGENATOR WAS ASSEMBLED. THE UNIQUE IDENTIFIER (UDI) NUMBER OF THE STERILE CONVENIENCE PACK IS (B)(4). THE INVOLVED REVOLUTION PUMP PC IS A NON-STERILE COMPONENT ASSEMBLED INTO A CONVENIENCE PACK THAT IS DISTRIBUTED IN THE USA. THE STAND ALONE REVOLUTION PUMP PC (CATALOG NUMBER 050300700) IS ALSO 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 PUMP PC. THE INCIDENT OCCURRED IN WICHITA, KANSAS, UNITED STATES OF AMERICA. ON (B)(6) 2022, THE INVOLVED CIRCUIT HAS BEEN RECEIVED AT LIVANOVA (B)(4) FOR INVESTIGATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. TO TRACE OF ALL AVAILABLE INFORMATION, AN ADDITIONAL CASE HAS BEEN SUBMITTED INTO LIVANOVA COMPLAINT DATABASE FOR THE INVOLVED EQUIPMENT. FOLLOW UP WITH THE CUSTOMER CLARIFIED THE FOLLOWING POINTS: PRIMING PHASE HAD NO ISSUE. EVERYTHING WAS BEHAVING NORMALLY UNTIL THEY WENT ON PUMP. IT WAS A REGULAR BYPASS CASE, 5 GRAFTS. THEY WERE ONLY ON BYPASS 3 MINUTES THE FIRST TIME WHEN THEY EXPERIENCED THE DROP IN FLOWS. PLANNED BLOOD FLOW WAS 6 LPM AT 300 RPM. AFTER CHANGING TO A NEW PUMP AND NEW CIRCUIT, THEY WERE ABLE TO ACHIEVE THEIR REQUIRED FLOW RATE OF 6 LPM. THE DURATION OF THE CHANGE-OUT IS UNKNOWN. ACT'S WERE CHECKED BEFORE GOING BACK ON PUMP WITH THE NEW CIRCUIT AND THEY WERE AT 450. ACT¿S WERE MEASURED AT 451 PRIOR TO GOING BACK ON. THEY WERE THEN KEPT AT A TARGETED RATE OF 480. THE PRE-OXYGENATOR-MEMBRANE-PRESSURE WAS NOT MONITORED AND IS ROUTINELY NOT MONITORED. THE INLET TO THE REVOLUTION WAS NEVER CLAMPED DURING THE PROCEDURE. ROUTINELY THEY DO NOT DO IT. BLOOD GASES WERE PERFORMED DURING THE CHANGE OUT AND AGAIN UPON GOING BACK ON PUMP AND ALL VALUES WERE WITHIN NORMAL PARAMETERS. THE CRNA SAID THE PATIENT PRESSURES NEVER FELL INTO A CRITICAL AREA. THERE WAS NO REPOSITIONING OF THE CANNULA. THE PERFUSIONIST SPECIFICALLY ASKED THE SURGEON IF HE WAS DOING ANYTHING LIKE THAT AND HE SAID HE HAD NOT. CANNULA WERE NOT CHANGED. THE CANNULAS WERE EXAMINED FOR CLOT CONCERNS, AND NONE WERE OBSERVED. PATIENT¿S ACT WAS 451 AT THE LOWEST. PERFUSION DID NOT ADMINISTER ANY DRUG WITH VASOCONSTRICTOR EFFECT. PATIENT PRESSURE WAS A LITTLE OVER 60. PATIENT¿S CONDITION AFTER THE CHANGE WAS FINE AND THEY WERE ABLE TO MOVE FORWARD WITH THE CASE. THE PATIENT CAME OFF PUMP FINE AND IT FINE. PUMP SHEET WILL NOT BE PROVIDED THE DISPOSABLE CIRCUIT IS AVAILABLE FOR INVESTIGATION. THE DESIGN HISTORY REVIEW (DHR) WAS PERFORMED AND HIGHLIGHTED THAT THE INVOLVED LOT WAS RELEASED AS CONFORMING ACCORDING TO SPECIFICATIONS. THE COMPLAINT DATABASE REVIEW DIDN¿T IDENTIFY ANY ADVERSE TREND ON SIMILAR ISSUES. THE INVOLVED DEVICE HAS BEEN RECEIVED FOR DETAILED INVESTIGATION, AND PRELIMINARY INSPECTION DIDN¿T IDENTIFY ANY EVIDENT DEFECT. INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
ON 20 SEPTEMBER 2022, DURING FOLLOW UP WITH THE CUSTOMER, LIVANOVA HAS LEARNED THAT THE VACUUM VALUES IN THE INSPIRE RESERVOIR VARIED BETWEEN 15 TO -35 MMHG. THE COMPLAINED REVOLUTION PUMP HAS BEEN RECEIVED AT LIVANOVA FOR INVESTIGATION. INITIAL VISUAL INSPECTION FOUND THE UPPER HUB AND THE IMPELLER SHOWED SOME DAMAGES. INVESTIGATION IS ON-GOING. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS OBTAINED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.
THE COMPLAINED REVOLUTION PUMP WAS RECEIVED AT LIVANOVA FOR INVESTIGATION. VISUAL INSPECTION FOUND THE UPPER HUB WAS PARTIALLY WORN AND THE IMPELLER WAS FOUND TO BE DAMAGED. THUS, THE IMPELLER LIFTED AND APPLIED EXCESSIVE PRESSURE ON THE UPPER BEARING CAUSING ITS DAMAGE. BASED ON THE INVESTIGATION PERFORMED FOR SIMILAR CASES, THE MOST PROBABLE ROOT CAUSES OF THE IMPELLER LIFT ARE: (I) EXCESSIVE NEGATIVE PRESSURE (BELOW -50 MMHG) APPLIED TO THE PUMP INLET DUE TO SUBOPTIMAL MONITORING OF THE INLET PRESSURE (II) CLOTS FORMATION IN THE BOTTOM OF THE PUMP DUE TO PATIENT CONDITIONS AND/OR ANTICOAGULANT MANAGEMENT NO DEVICE MALFUNCTION COULD BE CONFIRMED. THE RISK IS IN THE ACCEPTABLE REGION. NO SPECIFIC ACTION WAS CURRENTLY DEEMED NECESSARY LIVANOVA WILL KEEP MONITORING THE MARKET.
LIVANOVA USA INC HAS RECEIVED A REPORT THAT AT THE BEGIN OF A CEC PROCEDURE, THE PERFUSIONIST NOTICED THAT AN INCREASED RPM'S ON THE SCP WAY HAS TO BE SET TO OBTAIN THE REQUESTED BLOOD FLOW. THE REVOLUTION SPEED WAS SET A 3500 REVOLUTION PER MINUTE (RPM) TO GET A BLOOD FLOW OF 5 LITER PER MINUTE (LPM). THE FLOW STARTED DROPPING TO 4 LPM, AND THEN TO 3 LPM, EVENT WITH THE PUMP SPEED INCREASED TO 3500 RPM. THE ARTERIAL PRESSURE ALSO DROP AS THE FLOW DROPPED. THE PERFUSIONIST HAS INFORMED THE SURGEON AND MEDICAL TEAM ELECTED TO CAME OFF BYPASS. WHEN THEY CHECKED THE DRIVER OF THE PUMP, THE HEARD A PITCHED NOISE FORM THE PUMP. HOWEVER, WHEN REPOSITIONED THE NOISE WENT AWAY. ADEQUATE FLOW COULD STILL NO ACHIEVED SO MEDICAL TEAM ELECTED TO CHANGE OUT THE ENTIRE PUMP AND CIRCUIT. BYPASS WAS COMPLETED WITH NO OTHER ISSUE. THERE IS NO REPORT OF ANY PATIENT INJURY.
SEE INITIAL REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2746380 | REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC COATING | PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE | KFM | SORIN GROUP ITALIA SRL | 2204280135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |